Recalls for Uncategorized

Hillrom Recalls Liko Multirall 200 Overhead Lift Due to Failure to Properly Attach Q-Link Strap Lock (Also Known as Q-Link 1 Strap Lock) to S65 Hook
02/22/2021 Medical Recall

The Liko Multirall 200 Overhead Lift is a general-purpose lift to move patients from room to room.

Pulse Oximeter Accuracy and Limitations: FDA Safety Communication
02/19/2021 Medical Recall

The FDA is informing patients and health care providers that pulse oximeters have limitations and a risk of inaccuracy that must be considered.

Boston Scientific Corporation Recalls EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) System Due to Risk of Short-Circuit
02/19/2021 Medical Recall

EMBLEM S-ICD is an implantable defibrillator. In some devices, moisture may get inside and keep the device from shocking the heart to fix heart rhythm.

Using Ventilator Splitters During the COVID-19 Pandemic - Letter to Health Care Providers
02/09/2021 Medical Recall

The FDA is informing that recent literature indicates that certain features are associated with better performance.

Ocean Beauty Seafood LLC Issues Allergy Alert on Undeclared Soy in Publix Brand Parmesan-Crusted Wild Alaskan Salmon Fillets 12 Oz. Package
02/08/2021 Food Recall

Ocean Beauty Seafood LLC of Seattle, WA is recalling 8450 packages of Publix brand Parmesan-Crusted Wild Alaskan Salmon Fillets, net wt.12oz, frozen, UPC 41415 30245 7, because it may contain undeclared soy due to mis-packaging

Shenandoah Growers, Inc Issues a Limited, Voluntary Recall of Specific Imported Organic Basil Because of Potential Health Risk
02/08/2021 Food Recall

Shenandoah Growers, Inc (Harrisonburg, VA) out of an abundance of caution, has issued a limited, voluntary recall of approximately 3240 units of branded fresh cut, packaged organic basil clamshells packed at its Indianapolis, Indiana location due to a possible health risk from Cyclospora. Cyclospori

Xeljanz, Xeljanz XR (tofacitinib): Drug Safety Communication -Initial Safety Trial Results Find Increased Risk of Serious Heart-related Problems and Cancer with Arthritis and Ulcerative Colitis Medicine
02/04/2021 Medical Recall

The FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with the arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib) compared to tumor necrosis factor (TNF) inhibitors.

Apotex Corp. Issues Voluntary Nationwide Recall of Enoxaparin Sodium Injection, USP Due to Mislabeling of Syringe Barrel Measurement Markings
02/03/2021 Medical Recall

Apotex Corp is voluntarily recalling two (2) batches of Enoxaparin Sodium Injection, USP to consumer level due to a packaging error resulting in some syringes barrels containing 150 mg/mL markings (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL stre

Boston Scientific Recalls EMBLEM S-ICD Subcutaneous Electrode (Model 3501) Due to Risk of Fractures
02/02/2021 Medical Recall

EMBLEM S-ICD Subcutaneous Electrode (Model 3501) is part of the Boston Scientific S-ICD System that helps detect heart activity and provides defibrillation therapy.

2021 Medical Device Recalls
01/29/2021 Medical Recall

List of Medical Device recalls in 2021.

Penumbra’s Recall of the JET 7 Reperfusion Catheter Due to Distal Tip Damage
01/29/2021 Medical Recall

The device is used in patients experiencing a stroke. The distal tip may become damaged, which may result in serious injury or death.

Genetic Variants of SARS-CoV-2 May Lead to False Negative Results with Molecular Tests for Detection of SARS-CoV-2 - Letter to Clinical Laboratory Staff and Health Care Providers
01/08/2021 Medical Recall

Laboratories should expect some false negative results because the SARS-CoV-2 virus can mutate over time and not be detected.

2021 Safety Communications
01/04/2021 Medical Recall

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.

Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19: FDA Safety Communication
01/04/2021 Medical Recall

This Safety Communication describes the risk of false results, particularly false negative results, with the Curative SARS-Cov-2 test. Recommendations for patients, caregivers and health care professionals are provided.

Precision Dose, Inc. Issues Voluntary Nationwide Recall of Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL Due to Microbial Contamination
12/31/2020 Medical Recall

Precision Dose, Inc. is voluntarily recalling all lots of Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL Unit Dose Cups bearing an expiration date from 1/31/2021 – 02/28/2022 (see specific lots below) to the consumer level

UPDATE: Perform Only Contained Morcellation When Laparoscopic Power Morcellation Is Appropriate: FDA Safety Communication
12/29/2020 Medical Recall

This update to the February 2020 safety communication provides information on the final guidance, Product Labeling for Laparoscopic Power Morcellators.

Cook Medical Recalls Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers Due to Separation in Device
12/23/2020 Medical Recall

Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers are catheters that help insert other medical devices used for therapy or diagnosis into the blood vessels during surgery.

Penumbra’s Urgent Voluntary Recall of JET 7 Catheters with Xtra Flex Technology Due to Increased Risk of Mortality and Serious Injury – Urgent Letter to Health Care Providers
12/15/2020 Medical Recall

Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) based on the risk of unexpected death or serious injury while used for removing clots in stroke patients

Wear Face Masks with No Metal During MRI Exams: FDA Safety Communication
12/07/2020 Medical Recall

The FDA is informing of a potential for injury during MRI while wearing a face mask that contains metal (such as surgical or non-surgical masks and respirators).

UPDATE: The FDA Reminds Patients and Health Care Providers of the Importance of At Least Yearly, Lifelong Follow-Up with Use of Endologix AFX Endovascular AAA Graft Systems: FDA Safety Communication
12/04/2020 Medical Recall

The FDA is updating our October 28, 2019 safety communication on the use of AFX endovascular grafts with Duraply material (AFX with Duraply or AFX2).

Baxter Healthcare Recalls Baxter SIGMA Spectrum Infusion Pumps with Master Drug Library (Versions 6 and 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software Due to Unplanned Shutdown Issues
12/01/2020 Medical Recall

Baxter Sigma Spectrum Infusion Pumps w/ Master Drug Library (V. 6 & 8) and Spectrum IQ Infusion Systems with DoseIQ Safety Software deliver fluids into the body

Shenandoah Growers Inc Issues a Limited, Voluntary Recall of Certain Imported Organic Basil Because of Potential Health Risk
11/24/2020 Food Recall

Shenandoah Growers, Inc (Harrisonburg, VA) out of an abundance of caution, has issued a limited, voluntary recall of approximately 15,000 units in select packages, due to a possible health risk from Cyclospora.

Fusion Health and Vitality Issues Voluntary Nationwide Recall of Core Essential Nutrients and Immune Boost Sublingual Vitamin D3 Due to the Unapproved Use of a Food Additive and Unapproved Marketing Statements
11/23/2020 Medical Recall

Fusion Health and Vitality LLC is voluntarily recalling all 2020 Lots of CORE essential nutrients and Immune Boost Sublingual Vitamin D3. CORE has been found to contain an unapproved food additive, hordenine HCl, rendering it adulterated. Immune Boost Labeling was found to contain statements that

Allergy Alert Issued for Undeclared Shrimp in Mislabeled Popcorn Chicken from 26 Whole Foods Market Stores
11/23/2020 Food Recall

Whole Foods Market is voluntarily recalling packaged popcorn chicken with sweet chili sauce across 26 stores in Northern California and Reno, Nevada.

Dole Fresh Vegetables Announces Limited Recall of Organic Romaine Hearts
11/21/2020 Food Recall

Dole Fresh Vegetables, Inc. is voluntarily recalling a limited number of cases of organic romaine hearts. The products being recalled are Dole™ Organic Romaine Hearts 3pk (UPC 0-71430-90061-1), combined English/French packaging, with Harvested-On dates of 10-23-20 and 10-26-20, and Wild Harvest Orga

Fresenius Kabi Issues Voluntary Nationwide Recall of a Single Lot of Dexmedetomidine Hydrochloride Injection Due to Cross-Contamination of Lidocaine
11/19/2020 Medical Recall

Fresenius Kabi USA is voluntarily recalling a single lot of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg /mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to a trace amount of lidocaine present in the lot. This recall is being performed to the

Hong Thai Foods Corp Issues Allergy Alert on Undeclared Milk Allergens in Golden Boy Custard Muffin Pandan
11/18/2020 Food Recall

Hong Thai Foods Corp. of Brooklyn, NY is recalling its 7.76 ounce packages of Golden Boy Custard Muffin Pandan because they may contain undeclared milk allergens.

Fresh Express Recalls Limited Quantity of Expired Fresh Express Kit Caesar Supreme Due to Potential Health Risk
11/18/2020 Food Recall

Fresh Express is voluntarily recalling a limited number of cases of expired 10.5 oz. Fresh Express Kit Caesar Supreme with the Use-by Date of November 8, 2020 and Product Code S296 because it may be contaminated with Escherichia coli STEC 026 bacteria. The recall is being executed out of an abundanc

Albright’s Raw Dog Food Recalls Chicken Recipe For Dogs Because of Possible Salmonella Health Risk
11/13/2020 Food Recall

Albright’s Raw Dog Food of Fort Wayne, IN is voluntarily recalling 67 cases of Chicken Recipe for Dogs because it has the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if

Kanan Enterprises Conducts Voluntary Recall of ALDI Southern Grove On the Go Sweet & Salty Trail Mix Due to Undeclared Almonds
11/12/2020 Food Recall

Out of an abundance of caution Kanan Enterprises announces the voluntary recall of ALDI Southern Grove On the Go Sweet & Salty Trail Mix 8 Pack Caddies 1.5 oz., Best By JUL 27 2021 due to the presence of almonds that are not listed as ingredients. People who have an allergy to almonds run the risk

Cook Medical Recalls Fixed Core Wire Guides, Due to Device Damage from a Manufacturing Error
11/12/2020 Medical Recall

The Cook Fixed Core Wire Guide is a curved wire guide made of stainless steel with non-reactive coating and helps insert medical devices into the body.

Lohxa LLC Issues Voluntary Nationwide Recall of Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination
11/09/2020 Medical Recall

Lohxa, LLC is voluntarily recalling Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free (NDC:70166-027-15) products bearing an expiration date from 01/31/21 – 03/31/21 (see specific lots below) to the consumer level. This product is sourced and repackaged from Sunstar Americas Inc. who has no

Stryker Neurovascular Recalls Trevo XP ProVue Retriever Due to Core Wire That May Break or Separate During Use
11/09/2020 Medical Recall

Stryker Neurovascular Recalls Trevo XP ProVue Retriever Due to Core Wire That May Break or Separate During Use

Tanimura & Antle Voluntary Recalls Packaged Single Head Romaine Lettuce Due to Potential E. Coli 0157:H7 Contamination
11/06/2020 Food Recall

Out of an abundance of caution, Tanimura & Antle Inc. is voluntarily recalling its packaged single head romaine lettuce under the Tanimura & Antle brand, labeled with a packed on date of 10/15/2020 or 10/16/2020, due to possible contamination with E. Coli 0157:H7. Packages contain a single head of r

Medtronic Recalls Rashkind Balloon Septostomy Catheters for Quality Issues
11/03/2020 Medical Recall

Medtronic Recalls Rashkind Balloon Septostomy Catheters for Quality Issues

Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 500 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit
11/03/2020 Medical Recall

Nostrum Laboratories, Inc. is voluntarily recalling 2 (two) lots of Metformin HCl Extended Release Tablets, USP 500 mg to the consumer level. The Metformin HCl Extended Release Tablets, USP 500 mg have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day as publish

Potential for False Positive Results with Antigen Tests for Rapid Detection of SARS-CoV-2 - Letter to Clinical Laboratory Staff and Health Care Providers
11/03/2020 Medical Recall

Laboratories should expect some false positive results when screening large populations with a low prevalence of COVID-19 infection.

Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit
11/02/2020 Medical Recall

Kansas City, Missouri, Nostrum Laboratories, Inc. is voluntarily recalling 2 (two) lots of Metformin HCl Extended Release Tablets, USP 750 mg to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg have been found to contain levels of nitrosamine impurities above the ADI limit

Natural Grocers Issues Voluntary Recall on Organic Elderberries Due to Potential Presence of Salmonella
10/29/2020 Food Recall

Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery retailer, is voluntarily recalling Natural Grocers Brand 4-ounce Organic Whole Elderberries after being notified by its supplier of the potential presence of Salmonella. Salmonella is an organism which can cause s

Baxter Issues Urgent Device Correction to Reinforce Important Safety Information Regarding Cleaning Practices of all Sigma Spectrum Infusion Pumps (V6, V8 and IQ)
10/29/2020 Medical Recall

Baxter International Inc. announced today it has issued an Urgent Device Correction to reinforce important safety information regarding cleaning practices of all Spectrum infusion pumps distributed in the United States, Canada, and the Caribbean, as deviations from the specified cleaning methods may

Allergy Alert Issued for Undeclared Egg in Prepared Macaroni & Cheese Sold at Whole Foods Market Stores in Five States
10/28/2020 Food Recall

Whole Foods Market is voluntarily recalling select prepared Macaroni & Cheese products from stores across five states because they contain undeclared egg. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume these produ

Sunstar Americas Inc. Issues Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination
10/28/2020 Medical Recall

Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 6/30/22 – 9/30/22 (see specific lots below) to the consumer level. This product may be contaminated with
the bacteria Burkholderia lata.

Homestead Creamery Issues Voluntary Glass Bottled Product Recall
10/28/2020 Food Recall

Homestead Creamery of Wirtz, VA is voluntarily recalling glass bottled products because of a suspected issue with the bottle sanitizing process. Glass bottled product in question may have a strong sanitizer odor which may affect the taste and quality of the product. There is no known health risk ass

Russ Davis Wholesale Issues Allergy Alert on Undeclared Egg in Mixed Veggie Cup With Dip
10/28/2020 Food Recall

Russ Davis Wholesale of Wadena, Minnesota is recalling individual serving cups of Mixed Veggie Cup with Dip because it may contain undeclared Egg. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume these products.

Allergy Alert Issued By Incredible Fish, Inc. for Undeclared Milk, Fish and Eggs in Incredible Stone Crab Mustard Sauce
10/24/2020 Food Recall

Incredible Fish, Inc. is voluntarily recalling a small quantity of Incredible Stone Crab Mustard Sauce because its labeling inadvertently did not identify the following allergens in the product: milk, fish, and eggs. People who have an allergy or severe sensitivity to milk, fish, or eggs run the ri

Orca Bay Foods, LLC Issues Allergy Alert on Undeclared Wheat and Milk Allergens in Gluten Free Battered Halibut
10/23/2020 Food Recall

Orca Bay Foods of Seattle, WA is recalling 4,450 lb. (356 cases) of 10 oz. retail box Trader Joe's brand Gluten Free Battered Halibut SKU 00503822, because it contains undeclared wheat and milk allergens.

Comercial Mexicana International Inc. Recalls “Tropique Assorted Fruit Jelly Bag 30/9PCS/10.06oz and Tropique Jelly Animal Jar 6/26oz ” Due to Possible Health Risk
10/22/2020 Food Recall

COMERCIAL MEXICANA INTERNATIONAL INC in Bethpage New York is recalling the product because it may pose a choking hazard. Small jelly cups containing seaweed extract (carrageenan) has been identified as a potential choking hazard in children

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Drug Safety Communication - Avoid Use of NSAIDs in Pregnancy at 20 Weeks or Later
10/15/2020 Medical Recall

FDA is warning that use of NSAIDs around 20 weeks or later in pregnancy may cause rare but serious kidney problems in an unborn baby. This can lead to low levels of amniotic fluid surrounding the baby and possible complications.

Hadson Toko Trading Co., Inc. Recalls Eishindo Mini Cup Jelly (50pcs) Because of Potential Choking Hazard
10/14/2020 Food Recall

HADSON (TOKO) TRADING CO., INC. OF MASPETH, NY is recalling its 28.2oz (800g) bags of EISHINDO MINI CUP JELLY (50 pcs) (迷你果凍杯(大)) due to the product being a potential choking hazard based off of its product size and consistency. Small jelly cups have previously been implicated in choking deaths of c

Red Monkey Foods, Inc. Recalls Parsley and Herbes De Provence Because of Possible Health Risk
10/13/2020 Food Recall

Red Monkey Foods, Inc. out of an abundance of caution is voluntarily recalling select organic parsley as part of a recall initiated by High Quality Organics (HQO). HQO has issued a recall for a lot of parsley because a sample was tested by one of HQO’s customers and was found to be potentially conta

Sauer Brands, Inc. Voluntarily Recalls Certain The Spice Hunter Products Because of Potential Salmonella Contamination
10/12/2020 Food Recall

Sauer Brands, Inc. is voluntarily recalling The Spice Hunter Products listed below due to the potential presence of Salmonella. After initially certifying that our raw material had tested negative for salmonella, and was fit for human consumption, our supplier notified us of the potential presence o

B&G Foods Issues Voluntary Allergy Alert for a Limited Number of Boxes of Back to Nature® Organic Rosemary & Olive Oil Stoneground Wheat Crackers Containing Peanut Butter Cookies
10/09/2020 Food Recall

B&G Foods announced today it is voluntarily recalling a very limited number of boxes of a single date code of 6 oz. Back to Nature Organic Rosemary & Olive Oil Stoneground Wheat Crackers,

Sunshine Mills, Inc. Expands Previously Announced Voluntary Recall of Certain Pet Food Products Due to Potentially Elevated Levels of Aflatoxin
10/08/2020 Food Recall

Sunshine Mills, Inc. is expanding its voluntary recall of certain pet food products that were made with corn that contained Aflatoxin at levels above FDA’s action levels.

Meijer Recalls Whole Cantaloupes and Select Cut Cantaloupe Trays Due to Potential Health Risk
10/07/2020 Food Recall

Meijer, in conjunction with Eagle Produce, LLC in Aguila, AZ., is announcing a voluntary recall of whole cantaloupe and select cut cantaloupe fruit trays and bowls. The recall is part of a sampling investigation by the Michigan Department of Agriculture and Rural Development and is due to the potent

Recommendations on Providing Clear Instructions to Patients Who Self-Collect an Anterior Nares (Nasal) Sample in a Health Care Setting for SARS-CoV-2 Testing - Letter to Health Care Providers
10/07/2020 Medical Recall

FDA's recommendations to health care providers on giving instructions to patients who self-collect an anterior nares sample for SARS-CoV-2 testing.

Marksans Pharma Limited Issues Expansion of Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg & 750mg, Due to the Detection of N-Nitrosodimethylamine (NDMA)
10/05/2020 Medical Recall

Marksans Pharma Limited, India is voluntarily expanding its earlier initiated recall on June 05, 2020 to include an additional 76 unexpired lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, & 750mg to the consumer level. Marksans performed N-Nitrosodimethylamine (NDMA) testing of

Country Fresh Expands Voluntary Recall
10/03/2020 Food Recall

Country Fresh is extending their voluntary recall issued on October 2, 2020 to include various containers of “Freshness Guaranteed “cut and/or sliced apples, grapes, mangos, pineapples and cantaloupe distributed by Walmart. The recall is a precautionary measure due to a possible health risk from L

Becton Dickinson CareFusion 303, Inc. Recalls Alaris™ System Pump Module and Pump Module Door Assembly Replacement Kits Due to the Potential for Stuck or Unresponsive Keys
10/02/2020 Medical Recall

Becton Dickinson CareFusion 303, Inc. Recalls Alaris System Pump Module and Pump Module Door Assembly Replacement Kits Due to the Potential for Stuck or Unresponsive Keys

Ashtel Studios Issues Voluntary Recall of Licensed Hand Sanitizers Packaged in 0.84 Fluid Ounce Pouches Due to Misbranding Because They Resemble Food and Drink Container Pouches
10/02/2020 Medical Recall

Ashtel Studios has announced a voluntary recall of all lots of licensed hand sanitizer packaged in .84 oz containers resembling food and drink pouches labeled with various children’s characters listed in the table below to the consumer level. The products are being recalled because they are packaged

Seneca Recalls Cinnamon Apple Chips Because of Possible Health Risk
10/02/2020 Food Recall

Seneca Snack Company, a Washington Corporation, is announcing a voluntary recall of Seneca Cinnamon Apple Chips and Clancy’s Cinnamon Apple Chips due to possible Salmonella contamination.

Country Fresh Voluntary Product Recall
10/01/2020 Food Recall

Country Fresh is initiating a voluntary recall of a limited quantity of watermelon chunks from select stores as a precautionary measure due to a possible health risk from Listeria monocytogenes detected on equipment used in packing this product.
FDA made these findings during a recent inspection.

DMM VISSION, S.A. DE C.V. Issues Voluntary Nationwide Recall of Cleaner Hand Sanitizer 500 mL and 1200 mL Bottles Due to the Possible Presence of Undeclared Methanol (Wood Alcohol)
09/30/2020 Medical Recall

Estado de México, México, DMM VISSION, S.A. de C.V. is voluntarily recalling five lots of Cleaner Hand Sanitizer, 500 mL and 1,200 mL plastic clear bottles with white tops currently in US distribution to the consumer level. This recall is being initiated out of abundance of caution due to detection

Potential Risk of Infection during Cardiac Surgery When Using the CardioQuip Modular Cooler-Heater Device – Letter to Health Care Providers
09/30/2020 Medical Recall

The FDA is providing new information about the risk of NTM infections in patients who have undergone cardiothoracic surgeries using heater-cooler devices.

Mammography Problems at Allison Breast Center at Monument Radiology in Richmond, Virginia: FDA Safety Communication
09/25/2020 Medical Recall

Mammography Problems at Allison Breast Center at Monument Radiology

Benadryl (diphenhydramine): Drug Safety Communication - Serious Problems with High Doses of the Allergy Medicine
09/24/2020 Medical Recall

FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) allergy medicine Benadryl (diphenhydramine) can lead to serious heart problems, seizures, coma, or even death.

Recommendations About the Use of Dental Amalgam in Certain High-Risk Populations: FDA Safety Communication
09/24/2020 Medical Recall

The FDA is providing recommendations for certain high-risk populations may be more vulnerable to potential adverse health effects of mercury exposure from dental amalgam.

Benzodiazepine Drug Class: Drug Safety Communication - Boxed Warning Updated to Improve Safe Use
09/23/2020 Medical Recall

The FDA is requiring the Boxed Warning be updated by adding other information to the prescribing information for all benzodiazepine medicines. This information will describe the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions across all the medicines in the class.

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of RIOMET ER™ (Metformin Hydrochloride for Extended-Release Oral Suspension) Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit
09/23/2020 Medical Recall

Sun Pharmaceutical Industries, Inc. (SUN PHARMA), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. is voluntarily recalling one lot of RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL to the consumer level. The reason for the recall is due to

Wismettac Asian Foods Voluntarily Recalls Dried Fungus Due to Potential Salmonella Contamination
09/23/2020 Food Recall

Wismettac Asian Foods, Inc., Santa Fe Springs, CA is issuing a voluntary recall for Shirakiku brand imported Dried Fungus (also known as Black Fungus or Kikurage) because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in yo

Real Pet Food Company of Phoenix, AZ Voluntarily Recalls One Lot of Billy+Margot Wild Kangaroo and Superfoods Recipe Dog Food in 4 lb Bags Because of a Possible Salmonella Health Risk (USA)
09/22/2020 Food Recall

Real Pet Food Company is voluntarily recalling Billy+Margot Wild Kangaroo and Superfoods Recipe 4lb bags because it has the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products. While no il

GHSW, LLC Issues Allergy Alert on Undeclared Milk and Egg Allergens
09/21/2020 Food Recall

GHSW, LLC. is voluntarily recalling 1512 units of Trader Joe’s Southwest Style Sweet Potato Sauté Bowl due to undeclared milk and egg allergens in the dressing that are not declared on the label. People who are allergic to milk and eggs run the risk of serious or life-threatening allergic reaction

BD Announces FDA Classifications for August 4th Recalls of BD Alaris™ System Hardware for Keypads, Incorrect Module Types and/or Sizes, and Channel Error
09/21/2020 Medical Recall

Three of the recalls, which BD announced on Aug. 4, 2020, have been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means that FDA has determined that there is a reasonable probability that the use of the product will cause serious adverse health consequences or d

Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Two Lots of NP Thyroid®, Thyroid Tablets, USP Due to Sub Potency
09/17/2020 Medical Recall

Acella Pharmaceuticals, LLC is voluntarily recalling one lot of 15-mg and one lot of 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because testing has found these lots to be sub potent. The product may have

Homestead Creamery Issues Allergy Alert on Undeclared Pecans in Chocolate Ice Cream Quart
09/17/2020 Food Recall

Homestead Creamery of Wirtz, VA is recalling one lot of Homestead Creamery chocolate ice cream quarts, dated 5/13/2021, because it may contain undeclared pecans. People who have an allergy or severe sensitivity to pecans run the risk of serious or life-threatening allergic reaction if they consume t

Becton Dickinson (BD) CareFusion 303 Inc. Recalls Alaris™Syringe and Alaris™PCA Modules Due to Potential Incorrect Display of Syringe Types and/or Sizes
09/16/2020 Medical Recall

The Alaris System is an infusion system. If parts of the PCA or Syringe Modules are damaged, incorrect syringe details may show, leading to inaccurate infusions.

Becton Dickinson (BD) CareFusion 303 Recalls Alaris System Infusion Pumps Due to Damaged Inter-Unit Interface Connectors, Loose or Missing Battery Screws and A Broken Upper and Lower Hinge Posts and Membrane Frame
09/14/2020 Medical Recall

The Alaris System Infusion Pump is the foundation of the infusion system. Multiple models are being recalled due to damaged IUI Connectors, loose or missing Battery Screws and broken upper and lower hinge posts and membrane frame.

Becton Dickinson (BD) CareFusion 303, Inc. Recalls Alaris™ System PC Unit and PC Unit Front Case Keypad Replacement Kits Due to Risk of Stuck or Unresponsive Keys
09/14/2020 Medical Recall

The Alaris System is an infusion system. The PC Unit Keys may become stuck or unresponsive and may lead to an infusion delay or prevent clinicians from changing fluid or medication infusions on the affected device.

Goodie Girl Tribeca LLC Recalls Goodie Girl Magical Animal Crackers Due to Undeclared Wheat
09/11/2020 Food Recall

Goodie Girl Tribeca LLC announced today it is voluntarily recalling 389 cases of a single date code of 7 oz. Goodie Girl Magical Animal Crackers, with a “best by” date of Jan 11, 21A3, after learning that the product may contain undeclared wheat ingredients. People who have an allergy or severe sens

Pretty Thai Issues Allergy Alert on Undeclared Peanuts in Mislabeled Peanut Sauce
09/10/2020 Food Recall

Pretty Thai of Austin, Texas, is recalling Pretty Thai Peanut Sauce that may have been mislabeled as Pretty Thai Sweet Chili Sauce. There is a risk that a person with an allergy or severe sensitivity to peanuts could unintentionally consume a product containing peanuts
because of this error.

Medek, LLC. Issues Voluntary Nationwide Recall of M Hand Sanitizer Due to Potential Presence of Methanol (Wood Alcohol) and Subpotent Ethanol Levels
09/10/2020 Medical Recall

Medek, LLC is voluntarily recalling all lots of M Hand Sanitizer Alcohol Antiseptic 80% 128 oz/3,785 mL to the consumer level. FDA analysis found the M Hand Sanitizer to contain methanol and be sub-potent for ethanol. Substantial methanol exposure can result in nausea, vomiting, headache, blurred v

FDA Reminds Users about the Importance of Following Instructions for the Cold-Therapy Mode of Water-Circulating Hot/Cold Therapy Devices: FDA Safety Communication
09/09/2020 Medical Recall

The U.S. Food and Drug Administration (FDA) wants patients and health care providers to know about the risk of injury that may happen to patients if the cold-therapy mode of water-circulating hot/cold therapy devices is not used correctly.

Fresco Foods, Inc. Issues Allergy Alert on Undeclared Fish (Anchovies) in Ancient Grain Jackfruit Bowl
09/03/2020 Food Recall

Fresco Foods Inc. of Tampa, FL is voluntarily recalling ALL units of ANCIENT GRAIN JACKFRUIT BOWL because it may contain an undeclared allergen, Fish (anchovies). People who have an allergy or severe sensitivity to Fish (anchovies) run the risk of serious or life-threatening allergic reaction if the

AJR Trading LLC Issues Voluntary Nationwide Recall of bio aaa Advance Hand Sanitizer 480 mL Bottles, Lot 20DF8307
09/03/2020 Medical Recall

Miami, Florida. AJR Trading is voluntarily recalling 2,004 units of lot 20DF8307 of bio aaa Advance Hand Sanitizer currently in US distribution, packaged in 480 mL bottles, to the consumer level. This lot of bio aaa Advance Hand Sanitizer has been tested and meets all appropriate specifications an

Conduct a Trial Stimulation Period Before Implanting a Spinal Cord Stimulator (SCS) - Letter to Health Care Providers
09/03/2020 Medical Recall

The FDA has reviewed serious side effects associated with implanted spinal cord stimulators.

CorgioMed LLC Issues Voluntary Nationwide Recall of All Lots of Leafree Instant Hand Sanitizer Aloe Vera Labeled as EDIBLE ALCOHOL
09/03/2020 Medical Recall

CorgioMed, LLC is voluntarily recalling all lots of Leafree Instant Hand Sanitizer-Aloe Vera, within expiry to the consumer level. The products are being recalled because they are labeled as “EDIBLE ALCOHOL”. Leafree Hand Sanitizer is an alcohol-based hand rub to be applied externally to reduce bac

RLC Labs, Inc., Issues Voluntary Nationwide Recall of All Lots of Nature-Throid® and WP Thyroid® with Current Expiry Due to Sub Potency
09/03/2020 Medical Recall

RLC Labs, Inc. is voluntarily recalling a total of 483 lots of Nature-Throid® and WP Thyroid® in all strengths, all counts of product within current expiry to the consumer level. The products are being recalled because testing of samples from six (6) lots by the U.S. Food and Drug Administration

Sunshine Mills, Inc. Issues Voluntary Recall of Certain Dog Food Products Due to Potentially Elevated Levels of Aflatoxin
09/02/2020 Food Recall

Sunshine Mills, Inc. is issuing a voluntary recall of certain dog food products due to levels of Aflatoxin that are potentially above the acceptable limit. Aflatoxin is a naturally occurring mold by-product from the growth of Aspergillus flavus and can be harmful to pets if consumed in significant

BD Provides Update on Previously Disclosed Recall of BD Alaris System Hardware
09/01/2020 Medical Recall

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today provided an update on a previously announced voluntary recall of the BD Alaris™ System. Three of the situations described in this recall, which BD announced on June 30, 2020, have been designated as Cl

The Protein Shoppe, LLC Issues Voluntary Nationwide Recall of the “Red- E” Male Enhancement Tablet Due to the Presence of Undeclared Sildenafil
09/01/2020 Medical Recall

The Protein Shoppe, LLC is voluntarily recalling all lots of “Red-E” (Male Enhancement tablet) to the consumer level. This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil, a Phosphodiesterase-5 (PDE-5) inhibitor which is the active ingred

Mylan Initiates Voluntary Nationwide Recall of Four Lots of Amiodarone HCl Injection, USP and Tranexamic Acid Injection, USP Due to Carton Label Mix-Up
08/31/2020 Medical Recall

Mylan N.V. (NASDAQ: MYL) today announced that its U.S.-based Mylan Institutional LLC business is conducting a voluntary nationwide recall to the hospital/clinic level of four lots of Amiodarone HCl Injection, USP 450 mg/9 mL, packaged in cartons of 10 single-dose 9 mL vials and Tranexamic Acid Injec

Open Book Extracts Issues Voluntary Nationwide Recall of All Lots of Always Be Clean Hand Sanitizer and Just Hand Sanitizer that are Labeled to Contain Methanol
08/29/2020 Food Recall

Open Book Extracts (OBX) is voluntarily recalling to the consumer level all lots of Always Be Clean Hand Sanitizer and Just Hand Sanitizer that are labeled to contain methanol.

TreeHouse Foods Announces Voluntary Recall of Certain Signature Select Granola Bars
08/28/2020 Food Recall

This recall is being conducted because the outer carton indicates that the product is Chocolate Chip variety, while some of the individually-wrapped product contained in the carton may be Peanut Butter & Chocolate Chip variety. People who have an allergy or severe sensitivity to peanuts run the risk

Stop Using Gowns, including Surgical Gowns, from Laws of Motion PPE - Letter to Health Care Providers
08/28/2020 Medical Recall

Gowns purchased from Laws of Motion have potential quality issues and should not be used as personal protective equipment.

Harmonic Nature Issues Voluntary Nationwide Recall of Hand Sanitizer Due to the Presence of 1-Propanol
08/28/2020 Medical Recall

Guadalupe, Nuevo Leon, Harmonic Nature is voluntarily recalling all 800 bottles Hand Sanitizer, 250mL, product due to the potential presence of 1-propanol. The products have been tested and found to contain 1 propanol. Any amount of 1-propanol with a concentration greater than or equal to 1% by v

Invokana, Invokamet, Invokamet XR (canagliflozin): MedWatch Safety Alert - Boxed Warning about Risk of Leg and Foot Amputations Removed
08/26/2020 Medical Recall

Based on FDA's review of new data from three clinical trials, the Boxed Warning about amputation risk from the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) prescribing information was removed.

Nanomateriales, Sa De CV Issues Voluntary Nationwide Recall of All Lots of Zanilast+gel Due to the Presence of 1-Propanol
08/26/2020 Medical Recall

Apodaca, Nuevo Leon, Nanomateriales is voluntarily recalling all lots of ZANILAST+ GEL, Sanitizer gel, to the consumer level. FDA laboratory analysis found ZANILAST+ GEL to contain 1-propanol. There is a reasonable probability of acute toxicity from ingestion which can cause central nervous system

B&G Foods Issues Voluntary Allergy Alert on Undeclared Milk in a Limited Number of Boxes of Back to Nature® Organic Rosemary & Olive Oil Stoneground Wheat Crackers
08/26/2020 Food Recall

B&G Foods announced today it is voluntarily recalling 1,502 cases of a single date code of 6 oz. Back to Nature Organic Rosemary & Olive Oil Stoneground Wheat Crackers, with a “best by” date of APR 07 2021, after learning that the product may contain undeclared milk ingredients.

Riviana Foods Inc. Voluntarily Recalls Certain Manufacturing Date and Upc Number of Ronzoni® Smart Taste® Extra-Wide Noodles Due to Possible Undeclared Egg Allergen
08/26/2020 Food Recall

Riviana Foods Inc. is voluntarily recalling 19,931 cases of certain coded Ronzoni Smart Taste Extra-Wide Noodle cellophane packages that contain an egg noodle product. The affected Ronzoni Smart Taste Extra-Wide Noodle packages do not declare the allergen “egg”, which is an ingredient in the noodle

Schaws Sauce Issues Allergy Alert on Undeclared Soy and Anchovies in Schaws Sweet and Sassy Gourmet Barbecue and Basting Sajuce and Schaws Sweet with Heat Barbecue and Basting Sauce
08/26/2020 Food Recall

Schaws Sauce of Iron River, Michigan is recalling two flavors of barbecue sauces, because the products contain undeclared Soy and Anchovies. People who have an allergy or severe sensitivity to Soy or Anchovies run the risk of serious life threatening allergic reaction if they consume these products.

Hostess Brands, LLC Expands Voluntary Recall of Certain Hostess® Raspberry Zingers® Due to the Potential for Mold
08/25/2020 Food Recall

Hostess Brands, LLC (“Hostess Brands”) is expanding its voluntary recall of certain Hostess® Raspberry Zingers® because the product may develop mold prior to the best by date.

Russ Davis Wholesale Recalls Peaches and Peach Salsa Because of Possible Health Risk
08/25/2020 Food Recall

Russ Davis Wholesale (RDW) is recalling Peach Salsa under the Crazy Fresh and Quick & Easy brands in an abundance of caution due to possible contamination with Salmonella. Salmonella may cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened

Asiaticon SA de CV Issues Voluntary Nationwide Recall of V-Klean Hand Sanitizer Gel, Medically Minded Hand Sanitizer Gel and Protz Real Protection Antibacterial Hand Sanitizer Due to Potential Presence of Methanol (Wood Alcohol) and Subpotent Ethanol Leve
08/25/2020 Medical Recall

Mexico City, Mexico, Asiaticon SA de CV (Mexico) is voluntarily recalling all lots of V-Klean Hand Sanitizer Gel, Medically Minded Hand Sanitizer Gel and Protz Real Protection Antibacterial Hand Sanitizer sold in 13.5, 16.9 and 33.8 ounce bottles to the consumer level. The products are being recalle

Sunshine Mills, Inc. Issues Voluntary Recall of Nature’s Menu® Super Premium Dog Food with a Blend of Real Chicken & Quail Because of Possible Salmonella Health Risk
08/25/2020 Food Recall

Sunshine Mills, Inc. is issuing a voluntary recall of Nature’s Menu® Super Premium Dog Food with a Blend of Real Chicken & Quail because of the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated produ

Frito Lay Issues Voluntary Allergy Alert on Undeclared Milk in Select Bags of Lay’s Barbecue Flavored Potato Chips
08/25/2020 Food Recall

Frito-Lay today issued a voluntary recall of select 1 oz., 1 1/2 oz., 2 5/8 oz., 7 3/4 oz., 12 1/2 oz., 15 1/2 oz. bags of Lay’s Barbecue Flavored Potato Chips because they may contain undeclared milk ingredients. These recalled bags may also be included in select Frito-Lay Variety Packs. People who

Smiths Medical Recalls Medfusion 3500 and 4000 Syringe Pumps Due to Risk of Medication Delivery Error
08/24/2020 Medical Recall

Medfusion 3500 and 4000 syringe pumps control fluid and drug delivery to patients. A software issue may cause over- or under- delivery, causing adverse events.

Prima® Wawona Recalls Bulk/Loose and Bagged Peaches Due to Possible Salmonella Risk
08/22/2020 Food Recall

Prima® Wawona of Fresno, California is voluntarily recalling all of its bulk/loose peaches distributed and sold from June 1 through August 3 and its bagged Wawona and Wawona Organic peaches distributed and sold from June 1 through August 19th because the products could possibly be contaminated with

Wegmans Food Markets, Inc. Announces Recall of Select Peaches and Various Products Containing Fresh Peaches Because of Possible Health Risk
08/22/2020 Food Recall

Wegmans Food Markets, Inc. is recalling a variety of bulk and bagged Wegmans and Wawona brand peaches, as well as in-store produced bakery items that contain fresh peaches because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infe

Frito-Lay Issues Voluntary Allergy Alert on Undeclared Milk in Small Number of Ruffles Original Potato Chips
08/21/2020 Food Recall

Frito-Lay announced a limited voluntary recall of a very small number of $1.29 1 1/2 oz. bags of Ruffles Original Potato Chips because they may contain undeclared milk ingredients. People who have an allergy or severe sensitivity to milk run the risk of a serious or life- threatening allergic reacti

Protective Barrier Enclosures Without Negative Pressure Used During the COVID-19 Pandemic May Increase Risk to Patients and Health Care Providers - Letter to Health Care Providers
08/21/2020 Medical Recall

The FDA is alerting health care providers and facilities that using protective barrier enclosures when treating COVID19 patients may pose increased health risks

Prima® Wawona Recalls Bagged Peaches Due to Possible Salmonella Risk
08/21/2020 Food Recall

Prima® Wawona of Fresno, California is voluntarily recalling its Wawona, Wawona Organic brand conventional and organic bagged peaches because the product could possibly be contaminated with Salmonella. Salmonella is a microorganism that can cause serious and sometimes fatal infections in young chil

Allergy Alert for Undeclared Soy (Soy Milk) in Vegan Vanilla Cake Issued by Whole Foods Market Stores in Seven States
08/20/2020 Food Recall

Whole Foods Market is voluntarily recalling Vegan Vanilla Cake from 21 stores across Alabama, Georgia, Mississippi, North Carolina, South Carolina, Tennessee and one store in Tallahassee, Florida, due to an undeclared soy (soy milk) allergen. People who have a food allergy or severe sensitivity to

Grupo Asimex De Mexico Sa De CV Issues Voluntary Nationwide Recall of All Lots of Florence Morris Antiseptic Hand Sanitizer Due to Presence of Methanol (Wood Alcohol) and Sub-Potent Ethanol
08/20/2020 Medical Recall

Grupo Asimex de Mexico SA de CV is voluntarily recalling all lots of FLORANCE MORRIS Antiseptic Hand Sanitizer, 70% Alcohol, packaged in 8 fl oz bottles and 1L bottles to the consumer level. The products have the potential to contain methanol (wood alcohol) and be sub-potent for the ethanol conte

Superior Nut Company Issues Allergy Alert on Undeclared Brazil Nuts in Product
08/20/2020 Food Recall

Superior Nut Company of Cambridge, MA is recalling Southern Grove Mixed Nuts Less than 50% Peanuts, because it may contain undeclared Brazil Nuts. People who have an allergy or severe sensitivity to Brazil nuts run the risk of serious or life-threatening allergic reaction if they consume these produ

Bayshore Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 750 mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
08/20/2020 Medical Recall

Bayshore Pharmaceuticals, LLC, Short Hills, NJ is voluntarily recalling one (1) lot of Metformin Hydrochloride Extended-Release Tablets USP, 500 mg, 1000 count bottles and one (1) lot of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 count bottles within expiry to the consumer lev

Urgent Onion Recall Notification
08/19/2020 Food Recall

HelloFresh has been informed by one of its ingredient suppliers that it is conducting a voluntary recall of its onions due to the potential presence of salmonella bacteria. Please discard all onions received from May 8 through July 31, 2020.

ALDI Voluntarily Recalls Assorted Peaches from Wawona Packing Company LLC Due to Possible Salmonella Enteritidis Contamination
08/19/2020 Food Recall

As a precautionary measure, ALDI is voluntarily recalling assorted peaches received from its supplier, Wawona Packing Company, due to possible SalmoneALDI has removed the affected peaches from select ALDI stores in Connecticut, Florida, Illinois, Iowa, Kentucky, Massachusetts, Marlla contamination.

Grupo Yacana México S.A.S De C.V. Issues Voluntary Nationwide Recall of All Lots of Yacana Hand Sanitizer Due to Potential Presence of Methanol (Wood Alcohol) and Sub-Potent Ethanol
08/18/2020 Medical Recall

Guadalupe, Nuevo León, Grupo Yacana México S.A.S de C.V. is voluntarily recalling All Lots of Yacana Hand Sanitizer, 70% Alcohol, 250 ml to the consumer level. The products have the potential to contain methanol (wood alcohol) and be sub-potent for the ethanol content.

Maison Terre Issues Voluntary Nationwide Recall of Organic Goldenseal Root Powder Due to Microbial Contamination
08/18/2020 Medical Recall

North Little Rock, AR, Maison Terre is voluntarily recalling all lots of its Goldenseal Root Powder, purchased from Starwest Botanicals, Sacramento, CA, and repackaged to the consumer level due to microbial contamination. FDA laboratory analysis of product samples found these products to be contami

Albek de Mexico S.A. de C.V. Issues Voluntary Nationwide Recall of All Hand Sanitizers Due to Potential Presence of Undeclared Methanol.
08/18/2020 Medical Recall

SAN JUAN del RIO QUERETARO, Mexico -- ALBEK de Mexico S.A. de C.V. is voluntarily recalling all lots and all brands of hand sanitizer currently in US distribution to the consumer level. The products were manufactured between November 7, 2019 and June 28, 2020. This recall is being initiated out of

SCA Pharmaceuticals (SCA) Is Issuing a Voluntary Nationwide Recall of Heparin Sodium Compounded Products Due to Incorrect Preservative (Benzyl Alcohol)
08/18/2020 Medical Recall

Windsor, CT, SCA Pharmaceuticals (SCA) is voluntarily recalling 10 lots of Heparin Sodium to the hospital/user level. The compounded Heparin Sodium bag contains the undeclared preservative benzyl alcohol. The labelling listed methylparaben and propylparaben as preservatives; however, are not presen

Risk of Inaccurate Results with Thermo Fisher Scientific TaqPath COVID-19 Combo Kit - Letter to Clinical Laboratory Staff and Health Care Providers
08/17/2020 Medical Recall

The FDA is alerting clinical laboratory staff and health care providers of a risk of false results with Thermo Fisher Scientific TaqPath COVID-19 Combo Kit.

SG24 LLC Issues Voluntary Nationwide Recall of SkinGuard24 Hand Sanitizer Labeled to Contain Methanol
08/15/2020 Medical Recall

SG24 LLC is voluntarily recalling the SkinGuard24 – All Day Hand Sanitizer products listed below to the consumer level.

Serafin Fishery Issues Allergy Alert on Undeclared Anchovies, Eggs, Milk and Soy in Salmon Dip and Whitefish Dip
08/13/2020 Food Recall

Serafin Fishery is recalling its 8-ounce containers of Salmon Dip and Whitefish Dip because they may contain undeclared anchovies, eggs, milk and soy. People who have allergies to anchovies, eggs, milk and soy run the risk of serious or life-threatening allergic reaction if they consume these produc

Abdallah Candies Issues Allergy Alert on Undeclared Almond in Lund’s and Byerly’s 16 Oz. Sea Salt Caramels
08/12/2020 Food Recall

Abdallah Candies of Apple Valley, MN is voluntarily recalling a limited quantity of Lund’s and Byerly’s 16 oz. sea salt caramels with code AC31 on the bottom of the box. The boxes contain sea salt almond caramels instead of sea salt caramels. Sea salt almond caramels contain almonds as an ingredien

Kroger Mid-Atlantic Recalls Cheese Dips Because of Possible Health Risk
08/12/2020 Food Recall

Kroger Mid-Atlantic is recalling cheese dips sold at stores located in Virginia, West Virginia and the eastern portions of Tennessee (Johnson City/Kingsport), Kentucky (Ashland) and Ohio (Belpre/Marietta/Proctorville) because they have the potential to be contaminated with Salmonella

Fry’s Food Stores Recalls Cheese Dips Because of Possible Health Risk
08/12/2020 Food Recall

Fry’s Food Stores is recalling select cheese dips sold because they have the potential to be contaminated with Salmonella

Fred Meyer Recalls Cheese Dips Because of Possible Health Risk
08/12/2020 Food Recall

Fred Meyer is recalling cheese dips sold in our delis because they have the potential to be contaminated with Salmonella

Kroger Delta Division Recalls Cheese Dips Because of Possible Health Risk
08/12/2020 Food Recall

Kroger Delta Division is recalling cheese dips sold in our deli departments because they have the potential to be contaminated with Salmonella

Smith’s Recalls Cheese Dips Because of Possible Health Risk
08/12/2020 Food Recall

Smith’s is recalling cheese dips sold at their stores because they have the potential to be contaminated with Salmonella

Kroger Recalls Cheese Dips Because of Possible Health Risk
08/12/2020 Food Recall

Kroger is recalling cheese dips sold at because they have the potential to be contaminated with Salmonella

Kader Exports Recalls Frozen Cooked Shrimp Because of Possible Health Risk
08/11/2020 Food Recall

Kader Exports, with an abundance of caution, is recalling certain consignments of various sizes of frozen cooked, peeled and deveined shrimp sold in 1lb, 1.5lb., and 2lb. retail bags. The product has been distributed nationwide from late February 2020 to Mid-May 2020 because it has the potential t

Progressive Produce Voluntarily Recalls Red and Yellow Onions Because of Possible Health Risk
08/10/2020 Food Recall

Progressive Produce LLC is voluntarily recalling a very limited quantity of red and yellow onions as a result of a recall initiated by Thomson International, Inc., which supplied affected onions to Progressive Produce. This recall is being made out of an abundance of caution due to the potential for

BD Announces Voluntary Recall of ChloraPrep™ 3 mL Applicator in Specific U.S. Territories and Countries
08/10/2020 Medical Recall

BD (Becton, Dickinson and Company), a leading global medical technology company, announced a voluntary recall on June 23, 2020 for specified catalog numbers of the ChloraPrep™ 3 mL applicator due to possible fungal contamination, which only affects climate zone IV regions in specific U.S. territorie

Spokane Produce Inc. Issues Recall of Products Containing Onions Because of Possible Health Risk
08/10/2020 Food Recall

Spokane Produce, Inc. of Spokane, WA is voluntarily recalling salsa products containing onions as a result of the expanded onion recall initiated by Thomson International, Inc., which resulted in a recall by Spokane Produce’s onion supplier. These recalls are due to concerns of the potential for con

FRESHOUSE II, LLC Voluntarily Recalls Select Mesh Bags and Bulk Shipments of Potatoes, Limes, Valencia Oranges and Lemons Because of Possible Health Risk
08/09/2020 Food Recall

Freshouse II, LLC of Salisbury, NC is recalling the following specific production lots, brands and weights of Valencia Oranges, Lemons, Limes, Organic Limes, and Red B Potatoes because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and som

Wegmans Food Markets, Inc. Announces Recall of Select Valencia Oranges, Lemons, and Various Products Containing Fresh Lemon Because of Possible Health Risk
08/09/2020 Food Recall

Wegmans Food Markets, Inc. is recalling its four-pound bag of Valencia Oranges, two-pound bag of lemons, bulk lemons, and a variety of in-store produced seafood and restaurant foods items that contain fresh lemon because they have the potential to be contaminated with Listeria monocytogenes, an orga

Soluciones Cosméticas Issues Voluntary Nationwide Recall of Bersih Hand Sanitizer Gel Due to The Potential Presence of Undeclared Methanol (Wood Alcohol): Updated August 7, 2020
08/09/2020 Medical Recall

Soluciones Cosméticas voluntary recalled all lots of Bersih Hand Sanitizer Gel Fragrance Free sold in 16.9 ounce bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol). This release provides additional information about the packaging f

Incredible Products Sa De Cv Issues Voluntary Nationwide Recall of Gelbac T Antibacterial Handgel
08/07/2020 Medical Recall

Incredible products sa de cv issues voluntary nationwide recall of gelbac t antibacterial handgel due to potential presence of undeclared methanol (wood alcohol)

Haven’s Kitchen Home, LLC Issues Allergy Alert on Undeclared Soy in Product
08/07/2020 Food Recall

Haven’s Kitchen, legally known as Haven’s Kitchen Home, LLC of New York, NY is voluntarily recalling one lot of Golden Turmeric Tahini sauce because it may contain Gingery Miso sauce which contains undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or lif

Ferring US Issues Voluntary Nationwide Recall of DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, STIMATE® Nasal Spray 1.5 mg/mL Due to Superpotency
08/05/2020 Medical Recall

Ferring Pharmaceuticals US is voluntarily recalling all lots on the market of DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, and STIMATE® Nasal Spray 1.5 mg/mL listed in the table below to the consumer level. These products are being recalled due to superpotency or a

CME America Updates Recall of BodyGuard Infusion Pump System Due to Risk of Over-, and Under-infusion
08/05/2020 Medical Recall

CME America BodyGuard® Infusion System Administration Sets because the pumps may have a slower than expected delivery of medication (under-infusion), or faster than expected delivery of medication (over-infusion) or a delay in therapy.

Roque Plast S.A. de C.V. Issues Voluntary Nationwide Recall of Command Brands Gel AntiBac Instant Hand Sanitizer Lots 200371-12, 200371OH-05, 170420OH-06, 170420OH-8 Due to Potential Presence of Methanol (Wood Alcohol)
08/04/2020 Medical Recall

Roque Plast S.A. de C.V. is voluntarily recalling lots 200371-12, 200371OH-05, 170420OH-06, 170420OH-8 manufactured by Roque Plast S.A. de C.V. of Command Brands Gel AntiBac Instant Hand Sanitizer to the consumer level. This recall has been initiated due purported potential presence of methanol indi

LABORATORIOS JALOMA S.A. de C.V. Issues Voluntary Recall of the Jaloma Antiseptic Hand Sanitizer Due to the Potential Presence of Undeclared Methanol
08/01/2020 Medical Recall

LABORATORIOS JALOMA S.A. de C.V. is voluntarily recalling all lots and all bottle sizes of the Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% With vitamin E to the consumer level. This recall has been initiated because FDA sampled the 500 mL product and found it to be contaminated with undeclar

Albek de Mexico S.A. de C.V. Issues Voluntary Nationwide Recall of All Hand Sanitizers Within Expiry Due to Potential Presence of Methanol (Wood Alcohol)
07/31/2020 Medical Recall

Albek de Mexico S.A. de C.V is voluntarily recalling all lots and all brands of hand sanitizer currently in US distribution to the consumer level. This recall is being initiated out of an abundance of caution due to detection of methanol in hand sanitizer samples manufactured by Albek when product

Risk of loss of coordination during water-related activities in Parkinson’s Patients with Deep Brain Stimulators: FDA Safety Communication
07/30/2020 Medical Recall

The FDA has received several reports of patients with deep brain stimulators for Parkinson’s Disease experiencing loss of coordination during water-related activities requiring coordinated movements (e.g. swimming). Patients should exercise caution when bathing.

Broncolin S.A. de C.V. Issues Voluntary Nationwide Recall of Herbacil Antiseptic Hand Sanitizer 70% Alcohol Due to Potential Presence of Undeclared Methanol (Wood Alcohol)
07/28/2020 Medical Recall

Broncolin S.A. de C.V is voluntarily recalling all lots of Herbacil Antiseptic Hand Sanitizer 70% Alcohol to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).

Resource Recovery & Trading, LLC.,Issues Nationwide Recall of Hand Sanitizer Due to Potential Presence of Methanol (Wood Alcohol) and Subpotency Ethyl Alcohol Company Announcement
07/27/2020 Medical Recall

RESOURCE RECOVERY & TRADING LLC, is voluntarily recalling all the lots manufactured by MXL Comercial S.A. de C.V. of Hand Sanitizer with the next information: HAND SANITIZER 70% Ethyl Alcohol Disinfectant Gel, packaged in 6.7 FL Oz. (200 ml) bottles, UPC 650240026020 and HAND SANITIZER Non-sterile S

4e Brands North America Issues Expanded Nationwide Voluntary Recall of Hand Sanitizer Due to Potential Presence of Undeclared Methanol (Wood Alcohol)
07/27/2020 Medical Recall

San Antonio, Texas, 4e Brands North America is voluntarily recalling all lots of Hand Sanitizer brands to the consumer level. These products are being recalled due to the potential presence of methanol (wood alcohol).

Wellements LLC Issues Allergy Alert On Undeclared Milk Allergen In Two Lots Of Iron Drops And Iron Drops Sample
07/24/2020 Food Recall

Wellements LLC of Scottsdale, Arizona, is issuing a voluntary recall of two lots of its 1oz/30ml bottle of Iron Drops (UPC 729609000098) liquid Dietary Supplement and the sample version being Iron Drops Sample liquid Dietary Supplement because they may contain an undeclared milk allergen. People who

Maquiladora Miniara S.A. de C.V. Issues Voluntary Nationwide Recall of Shine and Clean Hand Sanitizer and Due to Potential Presence of Undeclared Methanol (Wood Alcohol)
07/24/2020 Medical Recall

Maquiladora Miniara S.A. de C.V. is voluntarily recalling lots of Shine and Clean Hand Sanitizer gel to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol) Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision,

Allergy Alert for Undeclared Egg In Kouign-Amann Pastries Issued By Select Whole Foods Market Stores In Seven States
07/24/2020 Food Recall

Whole Foods Market is voluntarily recalling Kouign-amann pastries in 35 stores across Colorado, Kansas, Missouri, Nebraska, New Mexico, Texas and Utah due to undeclared eggs. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if the

Real Clean Distribuciones SA de CV Issues Voluntary Nationwide Recall of Four Hand Sanitizer Due to Potential Presence of Undeclared Methanol (Wood Alcohol)
07/24/2020 Medical Recall

La Loma, Tlalnepantla, Mexico, Real Clean Distribuciones SA de CV is voluntarily recalling all lots it manufactured within expiry of the following brand names of hand sanitizers: Substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures,

Allergy Alert for Undeclared Tree Nut (Almond) In Chantilly Key Lime Tartlets Issued By Whole Foods Market Stores In Five States
07/24/2020 Food Recall

Whole Foods Market is voluntarily recalling Chantilly Key Lime Tartlets from stores in Connecticut, Maine, Massachusetts, New Hampshire and Rhode Island due to an undeclared tree nut (almond) allergen. People who have a food allergy or severe sensitivity to almonds run the risk of serious or life-th

UpSpring LLC Issues Allergy Alert On Undeclared Milk In " UpSpring Baby Iron + Immunity "
07/23/2020 Food Recall

UpSpring LLC of Austin, TX is recalling one batch of its 60 ml dark brown glass bottles sold in cartons of "UpSpring Baby Iron + Immunity" dietary supplements because it may contain undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of serious or life-thr

Opioid Pain Relievers or Medicines to Treat Opioid Use Disorder: MedWatch Safety Alert - FDA Recommends Health Care Professionals Discuss Naloxone with All Patients when Prescribing
07/23/2020 Medical Recall

The FDA is requiring drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder to add new recommendations about naloxone to the prescribing information.

Fresenius Kabi Issues Voluntary Nationwide Recall of Two Lots of Dexmedetomidine Hydrochloride Injection Due to Cross-Contamination of Lidocaine
07/22/2020 Medical Recall

Fresenius Kabi USA is voluntarily recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg / mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to the possibility of a trace amount of lidocaine present in these two lots and our investig

FDA Reminds Owners and Operators About Repair and Maintenance of Tanning Beds and Booths: FDA Safety Communication
07/22/2020 Medical Recall

The FDA is reminding owners and operators about repair and maintenance of tanning beds and booths. Owners and operators of tanning beds and booths should perform maintenance recommended by product manufacturers to reduce risk of smoke and fire.

Hostess Brands, LLC Issues Voluntary Recall of Certain Hostess® Raspberry Zingers® Due to the Potential for Mold
07/20/2020 Food Recall

Hostess Brands, LLC (“Hostess Brands”) is voluntarily recalling certain Hostess® Raspberry Zingers® because the product may develop mold prior to the best by date.

LIQ-E S.A. de C.V. Issues Voluntary Recall of the Optimus Instant Hand Sanitizer Due to the Potential Presence of Undeclared Methanol
07/20/2020 Medical Recall

LIQ-E S.A. de C.V. is voluntarily recalling all lots and all bottle sizes of The OPTIMUS Instant Hand Sanitizer due to the potential presence of methanol (wood alcohol) that were shipped into the United States. The products were manufactured between April 27, 2020 and May 08, 2020.

Allergy Alert Issued by Winter Gardens Quality Foods, Inc. for Undeclared Egg in Spinach Artichoke Dip
07/17/2020 Food Recall

Winter Gardens Quality Foods, Inc., is voluntary recalling one of its products: Whole Foods Market Spinach Artichoke Dip carrying the lot code 248 and Use By: 07/26/20, because of an undeclared allergen (Egg). Consumers who have a food allergy or have severe sensitivity to Egg should not consume the

Verathon, Inc., GlideScope® Core One™ TouchSmart Cable (“OneTouch cable”), Due to partial or complete loss of image during use
07/17/2020 Medical Recall

The Core OneTouch Smart Cable is used to connect the GlideScope Spectrum Single-use video laryngoscopes and GlideScope Video Baton 2.0 (Large) to the Core 10 and Core 15 video monitors. If too much force is used to twists the cable to connect the blade in the HDMI port or to the connection port. The

InHe Manufacturing, LLC and MHR Brands Issues Voluntary Nationwide Recall of Several Products Due to Potential Health Risk for Excess Lead
07/17/2020 Medical Recall

InHe Manufacturing, LLC and MHR Brands Issues Voluntary Nationwide Recall of Several Products Due to Potential Health Risk for Excess Lead

Giant Eagle Recalls Dried Fruit Mix Due to Undeclared Allergens
07/17/2020 Food Recall

Giant Eagle, Inc. has issued a voluntary recall of Giant Eagle Dried Island Fruit Mix due to the possibility the product may contain undeclared Peanut, Almond, Milk and Soy allergens

Verathon, Inc. Recalls GlideScope Core One TouchSmart Cable (“OneTouch cable”), Due to partial or complete loss of image during use
07/17/2020 Medical Recall

The Core OneTouch Smart Cable is used to connect the GlideScope Spectrum Single-use video laryngoscopes and GlideScope Video Baton 2.0 (Large) to the Core 10 and Core 15 video monitors. If too much force is used to twists the cable to connect the blade in the HDMI port or to the connection port. The

Happy Colon Foods, LLC Issues Allergy Alert on Undeclared Milk in Happy Colon Yum Shortbread Cookie and Happy Colon Mmmm Chocolate Chip Cookie
07/15/2020 Food Recall

Happy Colon Foods, LLC of Oklahoma City, Oklahoma is recalling Happy Colon YUM Shortbread Cookie and Happy Colon Mmmm Chocolate Chip Cookie, because they may contain undeclared milk.

AAA Cosmética, S.A. de C.V. Issues Voluntary Nationwide Recall of all Lots Within Expiry of bio aaa Advance Hand Sanitizer 480 mL Due to the Potential Presence of Undeclared Methanol (Wood Alcohol)
07/14/2020 Medical Recall

AAA Cosmética, S.A. de C.V. is voluntarily recalling all lots of bio aaa Advance Hand Sanitizer currently in US distribution, packaged in 480 mL bottles, to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).

Soluciones Cosméticas Issues Voluntary Nationwide Recall of Bersih Hand Sanitizer Gel Due to the Potential Presence of Undeclared Methanol (Wood Alcohol)
07/14/2020 Medical Recall

Soluciones Cosméticas is voluntarily recalling all lots of Bersih Hand Sanitizer Gel Fragrance Free sold in 16.9 ounce bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).

Flagstone Foods, LLC. Issues Voluntary Recall of Wegmans Pecan Blend Due to Undeclared Almonds and Walnuts
07/13/2020 Food Recall

Flagstone Foods LLC, of Robersonville, NC, is recalling its 16-ounce packages of Wegmans Pecan Blend Trail Mix because they may contain undeclared almonds and walnuts. The product comes in a 16-ounce, plastic stand-up resealable package, marked with UPC Code 0-77890-31040-3 and lot code #05M04300 on

4e Brands North America Issues Nationwide Voluntary Recall of Hand Sanitizer Due to Potential Presence of Undeclared Methanol (Wood Alcohol)
07/13/2020 Medical Recall

4e Brands North America is voluntarily recalling ten (10) bottle sizes of Hand Sanitizers to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol)

Ridley Block Operations Voluntarily Recalls Ultralyx® 12% Protein Sheep
07/10/2020 Food Recall

Ridley Block Operations is voluntarily recalling Ultralyx® 12% Protein Sheep with batch number HB01679401. The product has been found to contain elevated levels of copper. With prolonged consumption, the affected product could potentially have adverse health effects on sheep, including reductions in

Sundial Herbal Products is Recalling Products Attached Because these Products were Misbranded. The Products are Currently Unapproved Drugs, Recall is Required by the Order
07/09/2020 Food Recall

To be in compliance with FDA Drug Regulations, Sundial is requesting an immediate recall, removal and return, of all Sundial Products, distributed from the period beginning January 1, 2014 through current, that have labeling containing/making drug claims stating the product(s) can diagnose, cure, mi

Endologix Issues Correction Notice for Ovation iX Abdominal Stent Graft System
07/08/2020 Medical Recall

Endologix® Inc. (Nasdaq: ELGX) (“Endologix” or the “Company”), a developer and marketer of innovative treatments for aortic disorders, today announced that a correction notice has been issued for the Ovation iX system, that identifies the root cause of polymer leaks. This voluntary action has been c

Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, 500mg and 1000mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
07/08/2020 Medical Recall

Lupin Pharmaceuticals Inc. is voluntarily recalling all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg to the consumer level. As part of the ongoing assessment and continuation of the dialog with the FDA, additional analysis revealed that certain tested batches wer

CME America Announces a Follow-Up on the Voluntary Recall of BodyGuard® Infusion System Administration Sets
07/08/2020 Medical Recall

As part of CME America's commitment to quality, following the previously announced recall (April 27, 2020) of the BodyGuard® Infusion Pump Systems, the company conducted additional flow-rate accuracy testing. This testing revealed that some infusion sets do not meet the ±5% delivery accuracy for the

Allergy Alert: KIND Issues Voluntary Recall Due to Undeclared Sesame Seeds in Oats & Honey
07/07/2020 Food Recall

KIND Healthy Snacks (KIND) is voluntarily recalling a limited number of Oats & Honey Granola with Toasted Coconut pouches due to the presence of sesame seeds, which is not listed as an ingredient in the product. The label does list “sesame seeds” under the “May Contain” statement.

Mylan Initiates Voluntary Nationwide Recall of One Lot of Daptomycin for Injection, Due to The Presence of Particulate
07/07/2020 Medical Recall

Mylan N.V. (NASDAQ: MYL) today announced that its U.S.-based Mylan Institutional LLC business is conducting a voluntary nationwide recall to the consumer level of one lot of Daptomycin for Injection, 500 mg/vial due to the presence of particulate matter found in one single-dose vial manufactured b

False Positive Results with BD SARS-CoV-2 Reagents for the BD Max System - Letter to Clinical Laboratory Staff and Health Care Providers
07/06/2020 Medical Recall

FDA warns lab staff that use of BD SARS-CoV-2 Reagents for the BD Max System may lead to false positive results.

ITECH 361 Issues Voluntary Nationwide Recall of All Clean Hand Sanitizer and Moisturizer and Disinfectant Due to The Potential Presence of Undeclared Methanol (Wood Alcohol)
07/06/2020 Medical Recall

ITECH 361 is voluntarily recalling 18,940 bottles of All Clean Hand Sanitizer, Moisturizer and Disinfectant sold in one liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).

Granules Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
07/06/2020 Medical Recall

Granules Pharmaceuticals, Inc., Chantilly, VA is voluntarily recalling twelve (12) lots of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 and 500 count bottles within expiry to the consumer level due to the detection of NNitrosodimethylamine (NDMA) levels above the Acceptable Dail

The J. M. Smucker Company Issues Voluntary Recall of One Lot of Natural Balance® Ultra Premium Chicken & Liver Paté Formula Canned Cat Food
07/03/2020 Food Recall

The J. M. Smucker Company today announced a voluntary recall of one lot of Natural Balance® Ultra Premium Chicken & Liver Paté Formula canned cat food due to health concerns likely associated with elevated levels of choline chloride.

Arrow International Inc. Recalls Arrow AutoCAT®2 and AC3 Optimus® IABP Series Due to Possible Breakdown of Motor Connector Wires
07/02/2020 Medical Recall

Arrow International is recalling the pumps because both devices have a part that may break, char, and discolor the motor connector wires.

Transliquid Technologies LLC Issues Voluntary Recall of Mystic Shield Protection Topical Solution Due to Presence of Undeclared Methanol for the States of California, Louisiana, Massachusetts, and Texas
07/02/2020 Medical Recall

Transliquid Technologies LLC is voluntarily recalling all Mystic Shield Protection Topical Solution, manufactured by Mystic Intl S.A. de C.V in Mexico City, and packaged in an 8.45 ounce (250 ml) bottles, to the consumer level.

Garland Ventures LTD Voluntary Recalls Five Cheese Stuffed Shells Because of Possible Health Risk
06/30/2020 Food Recall

Garland Ventures Ltd of Garland, Texas is voluntary recalling 1095 cases of Five Cheese Stuffed Shells trays because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people,

Salad Supplier Recall Expanded after Potential Cyclospora Contamination; Hy-Vee Pulls Additional Salads as a Result
06/29/2020 Food Recall

Hy-Vee, Inc., based in West Des Moines, Iowa, is recalling an additional 12 salads across its eight-state region due to the potential that they may be contaminated with Cyclospora.

UVT, INC. Issues Voluntary Nationwide Recall of SANIDERM ADVANCED HAND SANITIZER Due to the Potential Presence of Undeclared Methanol (Wood Alcohol)
06/29/2020 Medical Recall

UVT, INC. is voluntarily recalling 38,830 liters of SANIDERM ADVANCED HAND SANITIZER, packaged in 1-liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol)

Allergy Alert for Undeclared Tree Nut in Red Velvet Cheesecake Slices Issued by Whole Foods Market Stores in California, Idaho, and Nevada
06/29/2020 Food Recall

Whole Foods Market is voluntarily recalling Red Velvet Cheesecake Slices from 36 stores in California, Boise, Idaho, and Reno, Nevada, due to an undeclared tree nut (walnut) allergen.

Norpac Fisheries Export Recalls Shrimp Poke Due to Possible Health Risk
06/28/2020 Food Recall

Norpac Fisheries Export is recalling all fresh shrimp poke distributed in the Hawaiian Island between May 11, 2020 and June 25, 2020 because it has potential to be contaminated with Listeria monocytogenes

Saniderm Products Voluntarily Issues Regional (Virginia, Maryland, New Jersey) Recall of 1 L Saniderm Advanced Hand Sanitizer bottles produced by Eskbiochem SA de CV Due to the Potential Presence of Undeclared Methanol (Wood Alcohol)
06/27/2020 Medical Recall

Saniderm Products (Saniderm) is voluntarily recalling Saniderm Advanced Hand Sanitizer, packaged in 1-liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol). In response to a recent news alert by the Food and Drug Administration

Fresh Express Issues a Precautionary Recall of Products Containing Iceberg, Red Cabbage and Carrots Produced at Its Streamwood, IL Facility Due to a Potential Cyclospora Risk
06/27/2020 Food Recall

Fresh Express, out of an abundance of caution, has issued a voluntary recall of branded and private label salad products produced at its Streamwood, IL facility that contain iceberg lettuce, red cabbage and/or carrot ingredients due to a possible health risk from Cyclospora. According to the Centers

Fresh Express Voluntarily Issues Recall of Limited Quantity of Marketside Classic Iceberg Salad
06/25/2020 Food Recall

Fresh Express, out of an abundance of caution, has issued a recall of a limited quantity of Marketside Classic Iceberg Salad from select stores as a precautionary measure due to a possible health risk from Cyclospora.

Beyond Better Foods, LLC Issues Allergy Alert on Undeclared Milk in Mislabeled Chocolate Peanut Butter Pints
06/24/2020 Food Recall

Beyond Better Foods, LLC, is recalling select pints from a single production run of Enlightened brand Chocolate Peanut Butter ice cream pints because they may have been packaged in Dairy-Free Chocolate Peanut Butter containers and thus contain undeclared milk ingredients

Chengdu Ai Qin E-Commerce Co., Ltd Issues Nationwide Recall of TTDEYE Brand Colored Contact Lenses
06/24/2020 Medical Recall

On June 18, 2020, Chengdu Ai Qin E-commerce Co., Ltd initiated a nationwide recall of 1362 pairs of colored contact lenses. The relevant series of contact lenses have been found to be distributed without FDA clearance and may pose a threat to health.

In Association with Fresh Express Inc., ALDI Voluntarily Recalls Little Salad Bar Garden Salad
06/23/2020 Food Recall

In cooperation with Fresh Express Inc., and out of an abundance of caution, ALDI has removed Little Salad Bar Garden Salad from select stores as a precautionary measure due to possible Cyclospora infection.

Mount Franklin Foods, LLC dba Azar Nut Company Issues Allergy Alert on Undeclared Peanuts in “7-Select Yogurt Pretzels”
06/23/2020 Food Recall

Mount Franklin Foods, LLC dba Azar Nut Company of El Paso, TX is voluntarily recalling its 5-ounce packages of "7-Select Yogurt Pretzels" because they may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life- threatening allergic reaction if they consume t

Golden Nutrition Inc. Recalls Anti-viral Immune Enhancement Because Labels Are Not in Compliance
06/23/2020 Food Recall

Golden Nutrition Inc. of Opa Locka, Florida is recalling four (4) Lots of Anti-Viral Immune Enhancement Capsules because the label makes unsubstantiated health claims. The recalled Anti-Viral Immune Enhancement were distributed to distributors through orders. The distribution is in Puerto Rico whe

Hy-Vee Recalls 12 OZ. Hy-Vee Garden Salad Product After Supplier Notes of Potential Cyclospora Contamination
06/22/2020 Food Recall

Hy-Vee, Inc., based in West Des Moines, Iowa, is recalling its 12 oz. Hy-Vee Bagged Garden Salad product across its eight-state region due to the potential that it may be contaminated with Cyclospora. The potential for contamination was brought to Hy-Vee’s attention when Fresh Express – which manufa

Flagstone Foods, LLC. Issues Voluntary Recall of North Star Sweet & Salty Caramel Trail Mix Due to Undeclared Allergen
06/22/2020 Food Recall

Flagstone Foods LLC, of Robersonville, NC, is recalling its 14-ounce packages of North Star Sweet & Salty Caramel Trail Mix because they may contain undeclared cashews. The product comes in a 14-ounce, plastic stand-up resealable package, marked with UPC Code 0- 80948-63064-4 and lot code # 05M042

Trident Seafoods Issues Voluntary Recall for Undeclared Allergen (Egg White) in Product
06/22/2020 Food Recall

Trident Seafoods is recalling Gordon Choice® Imitation Crab Supreme Style, because it may contain undeclared egg white. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products.

Jewel-Osco Voluntarily Recalls Bagged Signature Farms Garden Salad Due to Possible Cyclospora Contamination
06/19/2020 Food Recall

In cooperation with the Fresh Express recall of bagged salads potentially linked to an outbreak of Cyclospora infections in the Midwest, Jewel-Osco is voluntarily recalling bagged Signature Farms Garden Salad sold in its stores in Illinois, Indiana, and Iowa.

Certain COVID-19 Serology/Antibody Tests Should Not Be Used - Letter to Clinical Laboratory Staff and Health Care Providers
06/19/2020 Medical Recall

FDA warns lab staff and health care providers about using certain COVID-19 Serology/Antibody Tests.

H-E-B Voluntarily Issues a Recall Hill Country Fare Juice Drinks are Being Voluntarily Recalled from H-E-B, Joe V’s and Mi Tienda Stores for Potential Milk Allergen
06/19/2020 Food Recall

H-E-B is voluntarily issuing a recall for gallon-sizes of Hill Country Fare Pink Lemonade, Citrus Punch, Fruit Drink and Grape Drink for the potential presence of a milk allergen.

Fresh Express Announces Precautionary Recall of a Limited Quantity of Southwest Chopped Kit Due to the Presence of Undeclared Allergens
06/18/2020 Food Recall

Fresh Express is voluntarily recalling a limited quantity of Fresh Express 11.5-ounce Southwest Chopped Kit with production codes G163B10A and G163B10B, UPC code 0 71279 30602 5 and use-by date of June 29 due to the presence of undeclared wheat, soy, cashews, and coconut. In some individuals the

GSK Consumer Healthcare Issues Voluntary Nationwide Recall of Children's Robitussin® Honey Cough and Chest Congestion DM and Children's Dimetapp® Cold and Cough Due to Dosing Cups Missing Some Graduation Markings
06/18/2020 Medical Recall

GSK Consumer Healthcare is voluntarily recalling to the retail level two lots (listed below) of Children’s Robitussin® Honey Cough and Chest Congestion DM and one lot of Children’s Dimetapp® Cold and Cough, due to the inclusion of incorrect dosing cups.

Remdesivir by Gilead Sciences: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of Treatment
06/15/2020 Medical Recall

FDA is warning health care providers that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir.

NOW Health Group Inc. Voluntarily Recalls NOW Real Food ®Raw Macadamia Nuts Because of Possible Health Risk
06/12/2020 Food Recall

NOW Health Group, Inc. (NOW), of Bloomingdale, Illinois, is voluntarily recalling its NOW Real Food® Raw Macadamia Nuts – Product Code 7119, Lot#3141055 – because this lot has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in youn

Rusty’s Seafood Market Issues Allergy Alert on Undeclared Allergens (Fish, Crustacean, Shellfish, Eggs, Milk, Soy, and Wheat) in all “Captain Rusty’s Seafood Dips”
06/12/2020 Food Recall

Rusty’s Seafood Market of Lorida, Florida, is recalling all five of its Captain Rusty’s Seafood Dips due to the presence of undeclared allergens. People who have allergies to fish (mahi, salmon, whiting, pollock, threadfin bream), crustacean shellfish (crab, lobster, shrimp), wheat, eggs, soy or mil

RONG SHING TRADING NY INC. of Brooklyn, NY is Recalling its 21.1oz (600g) of Xi Zhi Liang Fruit Jelly Cup
06/11/2020 Food Recall

RONG SHING TRADING NY INC. of Brooklyn, NY is recalling its 21.1oz (600g) of Xi Zhi Liang Fruit Jelly Cups (喜之郎什果果凍杯), container code, “BEST BEFORE 12.30.2020,” because they may pose a choking hazard. Small jelly cups containing konjac powder have previously been implicated in choking deaths of chi

Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of One Lot of Metformin Hydrochloride Extended-Release Tablets USP, 500mg Due to the Detection of N-Nitrosodimethylamine (NDMA)
06/11/2020 Medical Recall

Lupin Pharmaceuticals Inc. is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets USP (generic equivalent of Fortamet®), 500mg, lot G901203 to the consumer level. FDA analysis revealed that this lot exceeded the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine

Teva Pharmaceuticals USA, Inc. Initiates Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP 500 mg and 750 mg Due to Detection of N-Nitrosodimethylamine (NDMA)
06/05/2020 Medical Recall

Teva Pharmaceuticals USA, Inc. is voluntarily recalling fourteen (14) lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, 100 and 1000 count bottles, in the United States to the consumer-level due to the detection of N-Nitrosodimethylamine (NDMA) levels in excess of the

Marksans Pharma Limited Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, Due to the Detection of N-Nitrosodimethylamine (NDMA)
06/05/2020 Medical Recall

Marksans Pharma Limited, India is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004, to the consumer level. FDA analysis has found the product to contain N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) of 96ng/da

Transport Media Safety Risk - Use Compatible Transport Media with SARS-CoV-2 Tests that Use Bleach - Letter to Clinical Laboratory Staff and Health Care Providers
06/04/2020 Medical Recall

FDA warns lab staff that exposure to cyanide gas may result from a reaction between transport media and testing platforms that are not compatible.

Two Neuromuscular Blocking Agents: CDER Alert - FDA Alerts Health Care Professionals to the Temporary Absence of Warning Statement on the Vial Caps
06/04/2020 Medical Recall

FDA is notifying health care professionals about the temporary absence of the “paralyzing agent” warning statement embossed on the vial caps of two neuromuscular blocking agents.

Epinephrine Auto-Injector Devices by Amneal and Impax: CDER Alert - FDA Alerts Patients and Health Care Professionals About Device Malfunction
06/01/2020 Medical Recall

FDA is alerting the public to immediately inspect certain lots of Amneal and Impax epinephrine auto-injector 0.3 mg to ensure the yellow “stop collar” in the device is present.

The FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients: FDA Safety Communication
06/01/2020 Medical Recall

FDA announces BIOCELL Textured Surface Allergan Breast Implants and Tissue Expanders Will No Longer Be Sold in the U.S.

Medtronic recalls StealthStation auto-registration feature due to inaccuracies during deep brain stimulation (DBS) procedures
06/01/2020 Medical Recall

StealthStation auto-registration feature helps guide surgeons to conduct deep brain stimulation (DBS) procedures. A software issue may lead surgeons to erroneously perform DBS procedures.

Allergan Aesthetics Launches Dedicated Multi-Channel Campaign to Contact Patients Who May Not Be Aware of The Biocell® Recall
06/01/2020 Medical Recall

Allergan Aesthetics, an AbbVie company (NYSE: ABBV), is initiating a new digital campaign to improve device tracking and further identify and reach breast implant patients who have, or have had, BIOCELL® breast implants and/or tissue expanders to inform them of the risk of BIA-ALCL. Since Jul

Amneal Pharmaceuticals LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, Due to Detection of N-Nitrosodimethylamine (NDMA) Impurity
06/01/2020 Medical Recall

Amneal Pharmaceuticals LLC Bridgewater, New Jersey (Amneal), is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, within expiry to the Retail Level.
Amneal was notified by the U.S. FDA that the Agency’s testing of seven lots of Metformin Hydr

CHS Nutrition Recalls Champion Meat Goat Pellets R20, Medicated Feed, Because of Possible Rumensin (monensin) Health Risk
05/29/2020 Food Recall

PGG/HSC Feed Company, LLC, dba CHS Nutrition of Hermiston, Oregon, is recalling 510 bags (50 lbs. each) of Champion Meat Goat Pellets R20, Medicated Feed due to elevated level of Rumensin (monensin). Monensin is an FDA-approved drug for use in certain animal feeds. However, if the feed contains exce

Apotex Corp. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets 500mg Due to the Detection of N-nitrosodimethylamine (NDMA)
05/28/2020 Medical Recall

Apotex Corp is voluntarily recalling all lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg within expiry to retail level. Apotex was notified by the U.S. Food and Drug Administration (US FDA) that one lot of Metformin Hydrochloride Extended-Release Tablets, USP was tested and showe

Medtronic Recalls HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief Due to Risk of Breaks and Tears During Set Up
05/28/2020 Medical Recall

These devices are parts of the The HeartWare Ventricular Assist System (HVAD). They attach to the HeartWare HVAD pump which helps the heart deliver blood to the rest of the body. The clamp screws are at risk of breaking when tightening the strain relief clamp and outflow graft tears have been observ

Use the Correct Cycle and Compatible N95 Respirators When Decontaminating Respirators with STERRAD Sterilization Systems - Letter to Health Care Providers
05/27/2020 Medical Recall

The FDA is reminding reprocessing staff in health care facilities to use the correct decontamination cycle associated with certain models of the ASP STERRAD Sterilization Systems to decontaminate compatible NN95 respirators.

Johnson Sea Products Issues Allergy Alert on Undeclared Wheat & Soy in “Home Style Crab Cakes”
05/22/2020 Food Recall

Johnson Sea Products of Coden, AL, is recalling its 12oz package of frozen “Home Style Crab cakes” because they contain undeclared ingredients of wheat and soy. People who have allergies to wheat or soy run the risk of serious or life-threatening allergic reaction if they consume these products.

Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Super Potency
05/22/2020 Medical Recall

Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30-mg, 60-mg and 90-mg NP Thyroid® (thyroid tablets, USP) to the consumer level. The products are being recalled because our testing has found these lots to be superpotent. The product may have up to 115.0% of the labeled amo

New Hoque and Sons, Inc. Recalls Radhuni Curry Powder Because of Possible Health Risk
05/21/2020 Food Recall

New Hoque and Sons, Inc. of Maspeth, NY is recalling Radhuni Curry Powder, contained in 400g plastic bottles, because it has the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others wi

Kent Nutrition Group Recalls Home Fresh Starter Amp Crumble Because of Elevated Salt Levels
05/20/2020 Food Recall

Kent Nutrition Group (KNG) of Muscatine, Iowa is voluntarily recalling 27- 25 lb.bags of Home Fresh Starter AMP Crumble from a single batch due to elevated salt levels, which can present illness or death to poultry.

Biota Biosciences Issues Voluntary Nationwide Recall of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables Because They Were Marketed Without FDA Approval
05/20/2020 Medical Recall

Biota Biosciences is voluntarily recalling the following lots in the table below of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables to the customer level.

Summitt Labs Issues Voluntary Nationwide Recall of KORE ORGANIC Watermelon CBD Oil Due to High Lead Results
05/15/2020 Medical Recall

Summitt Labs is voluntarily recalling Batch#730 Lot#K018 of KORE ORGANIC Watermelon CBD Oil Tincture, 30 ml bottle, 15mg 450x to the consumer level. The Florida Department of Agriculture and Consumer Services tested a random sample and found the product to contain lead levels at 4.7 ppm.

Ramar Foods Recalls Mint Chocolate Chip With Hidden Spinach Ice Cream Because of Possible Health Risk
05/15/2020 Food Recall

Ramar Foods of Pittsburg, CA, is recalling its 14 ounce packages of Peekaboo branded Mint Chocolate Chip with Hidden Spinach Ice Cream product out of an abundance of caution because of the potential contamination of Listeria monocytogenes, an organism which can cause serious and sometimes fatal infe

Mellace Family Brands California Inc. (Johnvince Foods) Recalls Wegmans Semi-Sweet Chocolate nonpareils, 18.5oz (1lb 2.5oz) 524g Due to Undeclared Milk Allergen
05/14/2020 Food Recall

MELLACE FAMILY BRANDS CALIFORNIA INC. (JOHNVINCE FOODS),located at 655 North River Road, Unit C, Warren Ohio 44483-2254, is recalling Wegmans Semi-Sweet Chocolate nonpareils, 18.5oz (1lb 2.5oz) 524g because it has undeclared MILK allergen on the retail label. People who have an allergy or severe sen

Applied Medical Recalls Python Embolectomy, BARD Embolectomy, and OTW Latis Cleaning Catheters Due to Risk of Separation During Use
05/12/2020 Medical Recall

The identified catheters are latex balloon catheters used for temporary blockage, closing of a blood vessel, or infusion of fluids. These catheters are at risk of tip detachment which could lead to pieces of the catheter breaking off. This could cause serious consequences.

MasterPharm, LLC. Issues Voluntary Nationwide Recall of Finasteride Plus 1.25mg Due to the Presence of an Undeclared Antihypertensive Drug
05/11/2020 Medical Recall

MasterPharm, LLC. is voluntarily recalling 1 lot of Finasteride Plus 1.25mg, capsules to the consumer level. The Finasteride Plus capsules have been found to contain undeclared minoxidil, an antihypertensive drug, at levels greater than those found in FDA approved products. The undeclared minoxidil

UNFI Voluntarily Recalls Wild Harvest® Organic Basil Due to Possible Health Risk
05/11/2020 Food Recall

United Natural Foods, Inc. (UNFI) is initiating a voluntary recall of a limited quantity of Wild Harvest® Organic Basil distributed out of UNFI’s Hopkins, MN distribution center to select retailers in Minnesota between 4/18/2020-5/8/2020. UNFI’s recall is issued out of an abundance of caution becaus

Zilk’s Plus Resources Issues Allergy Alert on Undeclared Milk, Soy, and Wheat in Select 12 Oz Bottled Sauces
05/08/2020 Food Recall

Zilk’s Plus Resources, LLC of Austin, TX announces a voluntary recall for select 12 oz bottles of Pluckers World Famous Wing Sauces because they may contain undeclared allergens.

ICU Medical Issues a Voluntary Nationwide Recall of Lactated Ringer's Injection, USP Due to the Presence of Particulate Matter
05/08/2020 Medical Recall

ICU Medical, Inc. is voluntarily recalling one single lot of Lactated Ringer's Injection, USP. The products are being recalled to the hospital/user level due to the presence of particulate matter identified as iron oxide. ICU Medical became aware of this issue through a single customer complaint

Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection - Letter to Health Care Providers
05/07/2020 Medical Recall

The FDA is concerned that certain respirators from China may not provide adequate protection to health care personnel based on testing by CDC NIOSH.

Risk of Misinterpreting Hydrogen Peroxide Indicator Colors for Vapor Sterilization: Letter to Health Care Providers
05/07/2020 Medical Recall

3M Comply Hydrogen Peroxide Chemical Indicator 1248 and Aesculap MD334 Process Indicator Card use different colors to indicate a sterilized device.

Becca Cosmetics voluntarily recalls Light Shifter Brightening Concealer
05/07/2020 Food Recall

Out of abundance of caution, and in line with its commitment to consumer satisfaction and safety, Becca Cosmetics is voluntarily recalling all shades of its Light Shifter Brightening Concealer because a brownish-black material identified as a common household mold was found on the sponge-tip applica

The Essential Baking Company Issues Allergen Alert on Undeclared Egg in 84 Loaves of 32 Oz. Sliced Columbia Bread
05/05/2020 Food Recall

The Essential Baking Company of Seattle, Washington is recalling 84 loaves of 32 oz. Sliced Columbia Bread, expiration date May 6.20, due to undeclared egg. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume this pro

Medifast Inc. Issues Allergy Alert on Undeclared Milk in OPTAVIA Essential Old Fashioned Maple & Brown Sugar Oatmeal
05/04/2020 Food Recall

Medifast, Inc. of Baltimore, Md., is recalling 24,923 boxes of OPTAVIA Essential Old Fashioned Maple & Brown Sugar Oatmeal because the product may contain undeclared traces of milk.

Mondelēz Global LLC Conducts Voluntary Recall of Limited Quantity of RITZ Cheese Cracker Sandwiches Family Size Product in the U.S. Due to Undeclared Peanut on Outer Packaging
05/01/2020 Food Recall

Mondelēz Global LLC announced today a voluntary recall of a limited quantity of RITZ Cheese Cracker Sandwiches Family Size (21.6 oz. carton) product in the United States. This recall is being conducted because the outer packaging indicates that the product is Cheese variety, while the individually-

Vascular Solutions, Inc. Recalls Langston Dual Lumen Catheter Due to Risk of Separation During Use
04/30/2020 Medical Recall

Vascular Solutions, Inc. recalled the Langston Dual Lumen catheter due to the inner catheter may separate during or after a high-pressure injection.

Condies Foods Issues Allergy Alert on Undeclared Soy Allergen in Chicken Salad on Croissant Single Item# 43237 and Chicken Sandwich on White Single Item# 43559
04/29/2020 Food Recall

Condies Foods of Kearns, UT is recalling 165 units of roll chicken salad on croissant single item# 43237 “USE THRU” 03/6/2020 05/6/2020, and sndw chicken sandwich on white single item# 43559 “USE THRU” 03/6/2020 05/2/2020. There is a possibility that this may contain undeclared soy allergen

CME America Provides Update on Two Previously Announced Voluntary Recalls Related to Ambulatory Infusion Pumps and Sets
04/29/2020 Medical Recall

CME America, a wholly owned subsidiary of BD (Becton, Dickinson and Company), a leading global medical technology company, today issued the following update regarding two previously announced voluntary recalls, one related to all models of CMEAmerica BodyGuard® infusion pumps (FDA Recall Number: Z-1

GSK Consumer Healthcare Recalls Benefiber Healthy Shape Prebiotic Fiber Supplement and Benefiber Prebiotic Fiber Supplement Due to Possible Plastic Contamination from the Bottle Cap
04/28/2020 Food Recall

GSK Consumer Healthcare is voluntarily recalling five lots (listed below) of Benefiber Healthy Shape Prebiotic Fiber Supplement powder and Benefiber Prebiotic Fiber Supplement powder due to the potential for green plastic pieces or shavings from bottle caps to be present in the product. There is a p

UPDATE: Potential Risks with Liquid-filled Intragastric Balloons - Letter to Health Care Providers
04/27/2020 Medical Recall

FDA continues to work with the manufacturers to evaluate reports of deaths in patients with liquid-filled intragastric balloon systems used to treat obesity.

UPDATE: Potential risks with liquid-filled intragastric balloons - Letter to Health Care Providers
04/27/2020 Medical Recall

The FDA is issuing this update to alert health care providers of five reports of unanticipated deaths that occurred from 2016 to present in patients with liquid-filled intragastric balloon systems used to treat obesity.

The FDA alerts health care providers about potential risks with liquid-filled intragastric balloons
04/27/2020 Medical Recall

The FDA has recently received multiple reports for two different types of adverse events associated with liquid-filled intragastric balloons used to treat obesity. The first type of adverse event involves balloon over-inflating and the second type is development of acute pancreatitis.

Surgical Mask and Gown Conservation Strategies - Letter to Health Care Providers
04/27/2020 Medical Recall

The FDA recognizes that the need for personal protective equipment (PPE), such as surgical masks, surgical and isolation gowns, and surgical suits, may outpace the supply available to health care organization during the Coronavirus Disease 2019 (COVID-19) outbreak.

UPDATE: Potential Risks with Liquid-filled Intragastric Balloons - Letter to Health Care Providers
04/27/2020 Medical Recall

An update on the potential risks of over-inflation (spontaneous hyperinflation), acute pancreatitis, and deaths in patients with Orbera and ReShape liquid-filled intragastric balloons used for weight loss in adult patients with obesity.

Fresenius Kabi's Recall of Ketorolac Results In QuVa Pharma® Recall of Compounded Sterile Product (R.E.C.K.)
04/27/2020 Medical Recall

QuVa Pharma, Inc. confirms that is working with the U.S. Food and Drug Administration, and voluntarily recalling all lots of R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50 ml in Sodium Chloride-60 ml BD syringe that were prepared using sterile Ketorolac being recalled by Fresenius Kabi

Hydroxychloroquine or Chloroquine for COVID-19: Drug Safety Communication - FDA Cautions Against Use Outside of the Hospital Setting or a Clinical Trial Due to Risk of Heart Rhythm Problems
04/24/2020 Medical Recall

FDA is concerned that hydroxychloroquine and chloroquine are being used inappropriately to treat non-hospitalized patients for coronavirus disease (COVID-19) or to prevent that disease.

Royal International Trading Inc Issues Alert On Undeclared Sulfites In “Tayni Boctoka Dry Fruits Mix Compot Apple”
04/22/2020 Food Recall

ROYAL INTERNATIONAL TRADING Inc of Brooklyn, NY is recalling its 500g (17.63oz) packages of "TAINY BOCTOKA DRY FRUITS MIX COMPOT APPLE" because they contain undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they c

Ocean Spray Cranberries, Inc Recalls Single Production Lot of 5.5 Oz Cans of Pink Lite Cranberry Juice Drink Because of Undeclared Sulfites
04/21/2020 Food Recall

Ocean Spray Cranberries, Inc. is recalling a single production lot of 5.5oz cans of Pink Lite Cranberry Juice Drink (listed below) because it may contain undeclared sulfites, which were erroneously added by a contract manufacturer.

Trividia Health, Inc. Issues Nationwide Voluntary Recall for an Isolated TRUE METRIX AIR Blood Glucose Meter with Serial Number TA1548753
04/21/2020 Medical Recall

Trividia Health, Inc. today announced it is initiating a nationwide voluntary recall of one (1) TRUE METRIX® AIR Blood Glucose Meter distributed in the United States to one customer (AssuraMed). The meter was not packaged into storebrand or retail branded packaging.

Allergy Alert Issued by Buckhead Meat and Seafood of Houston, Inc. for Undeclared Wheat, Soy, Milk, Fish and Eggs in Frozen Flounder Stuffed with Seafood
04/21/2020 Food Recall

Buckhead Meat and Seafood of Houston, Inc., a Sysco Company, is voluntarily recalling a small quantity of frozen Flounder Stuffed with Seafood because its labeling inadvertently did not identify the following allergens in the product: wheat, soy, milk, fish, and eggs.

B. Braun Medical Inc.Issues VoluntaryNationwideRecall of One (1) Lot ofCeftazidime for Injection USP and Dextrose Injection USP (50 mL), Duplex ContainerDueto Out-of-Specification Results for High Molecular Weight Polymers
04/20/2020 Medical Recall

Braun Medical Inc. (B. Braun) is voluntarily recalling one (1) lot of 2g Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 ml) in Duplex® Container to the hospital/user level.. During stability testing of Batch H8J812, test results were found to exceed the specification limits fo

Fresenius Kabi Issues Voluntary Nationwide Recall of 13 Lots of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter in Reserve Samples
04/20/2020 Medical Recall

Fresenius Kabi USA, LLC is voluntarily recalling 13 lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter

Important Information on the Use of Serological (Antibody) Tests for COVID-19 - Letter to Health Care Providers
04/17/2020 Medical Recall

The FDA recommends that health care providers continue to use serological tests intended to detect antibodies to SARS-CoV-2 to help identify people who may have been exposed to the SARS-CoV-2 virus or have recovered from the COVID-19 infection.

Allergy Alert Issued for Undeclared Cashews in Queso Sauce Sold at a Single Whole Foods Market Store in Phoenix, Arizona
04/16/2020 Food Recall

The Whole Foods Market store located at 7111 E Mayo Blvd. Phoenix, AZ 85054 is voluntarily recalling Queso Sauce because it may contain cashews (a tree nut). People who have an allergy or severe sensitivity to tree nuts run the risk of a serious or life-threatening allergic reaction if they consume

Avet Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Tetracycline HCl Capsules USP, 250 mg and 500 mg Due to Failed Dissolution Specifications
04/16/2020 Medical Recall

Avet Pharmaceuticals Inc. (“Avet”), based in East Brunswick, New Jersey, is initiating a voluntary recall of the following lots of Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles listed in the table below to the consumer/user level. These drug products are manufactured by Avet Ph

Auromedics Pharma LLC Issues Voluntary Nationwide Recall of Product Ampicillin and Sulbactam for Injection USP 1.5 g/ Vial, Due to Presence of Glass Particles in the Vial
04/15/2020 Medical Recall

AuroMedics Pharma LLC is voluntarily recalling lot AFO l 17001-A, Expiry date Dec 2018, of Ampicillin and Sulbactam for Injection USP, 1.5 g (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g Sulbactam as the sodium salt) in a Single-Dose vial, to the hospital level. The product has been found to contain glass particles.

International Laboratories, LLC Issues Voluntary Nationwide Recall of One (1) Lot of Clopidogrel Tablets USP, 75 mg Packaged in Bottles of 30 Tablets Due to Mislabeling NDC # 54458-888-16; Lot # 117099A
04/15/2020 Medical Recall

International Laboratories, LLC is voluntarily recalling Lot# 117099A of Clopidogrel Tablets, USP 75 mg, packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Clopidogrel tablets USP 75 mg but may contain Clopidogrel 75mg or Simvastatin Tablets USP 10 mg.

Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Nizatidine Oral Solution, 15 mg/mL, Due to Potential Levels of N-nitrosodimethylamine (NDMA) Impurity Amounts Above the Levels Established by FDA
04/15/2020 Medical Recall

Amneal Pharmaceuticals, LLC, Bridgewater, New Jersey is voluntarily recalling three lots of Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL), packaged in 480 mL bottles to the Consumer Level. Nizatidine Oral Solution was distributed by Gemini Laboratories, LLC, a wholly owned subsidiary of Amneal Phar

Baxter Expands Voluntary Nationwide Recall to Include Second Lot of Nexterone Injection Due to Presence of Particulate Matter
04/14/2020 Medical Recall

Following the issuance of a voluntary recall dated November 10, 2017 of one lot of NEXTERONE (amiodarone HCl) 150 mg/100 mL Premixed Injection, Baxter International Inc. announced today it is expanding the recall to include a second lot (NC109123) of NEXTERONE due to the potential presence of particulate matter.

Pharmedium Services, LLC Expands Voluntary Nationwide Recall of Additional Lots of Compounded Sterile Products Within Expiry Due to Lack of Sterility Assurance
04/14/2020 Medical Recall

January 10, 2018 Lake Forest, IL PharMEDium Services, LLC (PharMEDium) is voluntarily expanding the recall issued on December 27, 2017 to include the below lots of sterile drug products to the hospital/user level due to a lack of assurance of sterility. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.

PharMEDium Services, LLC Issues Voluntary Nationwide Recall of Certain Lots of Compounded Sterile Products Due to Lack of Sterility Assurance
04/14/2020 Medical Recall

December 27, 2017 Lake Forest, IL PharMEDium Services, LLC (PharMEDium) is voluntarily recalling the below lots of drug products to the hospital/user level due to a lack of assurance of sterility. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. To date, PharMEDium has not received any reports of complaints related to the products but is issuing this recall out of an abundance of caution following a commitment made during a recent inspection of the company’s facility.

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Levofloxacin in 5% Dextrose 250mg/50mL Due to Presence of Visible Particulate Matter Tentatively Identified as Mold
04/14/2020 Medical Recall

FOR IMMEDIATE RELEASE – 01-12-2018 – East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling one lot of Levofloxacin in 5% Dextrose Injection 250mg/50mL in a Single-Use flexible container NDC 55150-243-46, Lot CLF160003, Expiry date May 2018, to the hospital level. The product has been found to contain visible particulate matter tentatively identified as mold. This problem was discovered as a result of a product complaint in which the contents of one flexible bag was found to contain white particulate matter

Use Caution with Implanted Pumps for Intrathecal Administration of Medicines for Pain Management: FDA Safety Communication
04/14/2020 Medical Recall

The FDA is providing recommendations and sharing important information with health care providers, pharmacists, compounders, patients and caregivers about the risks of using medications delivered into the spinal fluid to treat or manage pain that are not approved for use with the implanted pumps.

Primus Announces a Voluntary Nationwide Recall of All Lots Within Expiry of Prescription Medical Food Limbrel® Due to Rare But Serious and Reversible Adverse Events While Seeking FDA's Cooperation to Restore Access for Patients with Medical Necessity
04/13/2020 Medical Recall

Primus Pharmaceuticals, Inc. of Scottsdale, Arizona is voluntarily recalling all unexpired lots of Limbrel products to the patient (user/consumer) level at FDA's request. FDA has requested a recall of Limbrel due to rare but serious and reversible side effects associated with Limbrel.

Magno-Humphries Laboratories, Inc., Issues Voluntary Nationwide Recall of Basic Drugs Brand of Senna Laxative Due to Mislabeling
04/13/2020 Medical Recall

Tigard, OR, Magno-Humphries Laboratories, Inc., is voluntarily recalling one lot of Basic Drugs Brand of Senna Laxative tablets, 8.6mg Sennosides to the consumer level due to a customer complaint that their bottle labeled as Senna Laxative actually contained Basic Drugs Brand of Naproxen Sodium 220mg. Naproxen Sodium 220mg tablet is used as a pain reliever and is a nonsteroidal anti-inflammatory drug (NSAID).

Kareway Products, Inc. Issues Voluntary Nationwide Recall of Gericare Eye Wash Due to Complaints Received on Potential Product Contamination which Compromises Sterility
04/13/2020 Medical Recall

Compton, California, Kareway Products, Inc is voluntarily recalling 60,000 lots of Gericare Eye Wash, Sterile Eye Irrigation Solution, 4 fluid ounces to the hospital, retail or consumer level. The product has been found to have potential microbial contamination which compromises sterility.

Apace Packaging LLC Issues Voluntary Nationwide Recall of Acyclovir (Lot 19900) Due to Product Mix-up
04/13/2020 Medical Recall

Apace Packaging LLC is voluntarily recalling one lot of Acyclovir Tablet, USP, 400mg, 50ct Unit Dose, NDC# 50268-061-15, Lot Number 19900, to the Retail level. These products have been recalled due to a product mix-up. A small number of blister cards containing Acyclovir Tablets, 400mg, UD Blister Cards may potentially also include Torsemide, 20mg, Tablets.

Hospira Issues a Voluntary Nationwide Recall for Labetalol Hydrochloride Injection, USP, Due to the Potential of Cracked Glass at the Rim Surface of the Vials
04/13/2020 Medical Recall

Hospira, Inc., a Pfizer company, is voluntarily recalling 3 lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL Vial (NDC 0409-2267-20), and one lot of Labetalol Hydrochloride Injection, USP, Novaplus® (NDC 0409-2267-25) to the hospital/institution level. Hospira, Inc. initiated this recall due to the discovery of cracks on the rim surface of vials for these lots, which is covered by the stopper and crimp seal.

DSD Merchandisers, Inc. Issues Allergy Alert on Undeclared Peanut in Roasted/Salted Deluxe Mixed Nuts in Deli Tubs.
04/11/2020 Food Recall

DSD Merchandisers, Inc. of Livermore CA is recalling 2040 individual 10oz deli tubs of Roasted /Salted Deluxe Mixed Nuts, because they may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they con

Ivermectin Intended for Animals: Letter to Stakeholders - Do Not Use in Humans as a Treatment for COVID-19
04/10/2020 Medical Recall

FDA is concerned about the health of consumers who may self-medicate by taking ivermectin products intended for animals, thinking they can be a substitute for ivermectin intended for humans.

Allergy Alert Issued for Undeclared Milk in Minestrone Soup Sold at Whole Foods Market Stores in 32 States and the District of Columbia
04/10/2020 Food Recall

Whole Foods Market stores are voluntarily recalling Minestrone Soup because the products may contain undeclared milk.

Fecal Microbiota for Transplantation: New Safety Information - Regarding Additional Protections for Screening Donors for COVID-19 and Exposure to SARS-CoV-2 and Testing for SARS-CoV-2
04/09/2020 Medical Recall

Because of the potential risk of transmission of SARS-CoV-2 via FMT, FDA has determined that additional protections are needed for any investigational use of FMT, whether under an Investigational New Drug Application (IND) on file with the FDA or under FDA’s enforcement discretion policy. No clinic

H&C Food Inc. Recalls Enoki Mushroom Because of Possible Health Risk
04/07/2020 Food Recall

H&C Food Inc. of Brooklyn, NY is recalling 7.05OZ (200G) Enoki mushrooms imported from Green Co. located in Korea, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly peopl

Boston Scientific Corporation Recalls Imager II Angiographic Catheters Due to Tip Detachment
04/07/2020 Medical Recall

The catheter tip can become detached during a patient procedure which could lead to serious injury or death.

LeMaitre Vascular Inc. Recalls LeMaitre Over the Wire Embolectomy Catheter Due to Balloon Deflation and Separation Issue
04/02/2020 Medical Recall

LeMaitre is recalling the Over the Wire Embolectomy Catheter because of the possibility of difficulty in balloon deflation during use.

Homestead Creamery Recall “Unsalted” Butter Because of Possible Health Risk
04/01/2020 Food Recall

Homestead Creamery Inc of Wirtz, VA, is recalling our unsalted butter because of the potential contamination of Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail, or elderly people, and others with weakened immune systems.

All Ranitidine Products (Zantac): Press Release - FDA Requests Removal
04/01/2020 Medical Recall

The FDA announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.

Medtronic Recalls Pipeline Flex Embolization Devices Due to Risk of Device Fracture
03/30/2020 Medical Recall

Medtronic is recalling their Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology because there is a risk the device could fracture during use.

CME America Recalls BodyGuard Infusion Pump System Due to Risk of Over-, and Under-infusion
03/30/2020 Medical Recall

The infusion pumps deliver fluids and medications. The affected infusion pumps and infusion pump systems lead to over- and under-infusion in patients.

Allergy Alert Issued By Winter Gardens Quality Foods, Inc. for Undeclared Milk in Vodka Sauce
03/26/2020 Food Recall

Winter Gardens Quality Foods, Inc., is voluntary recalling one of its products: Whole Foods Market Vodka Sauce carrying the lot code 20057, because of an undeclared allergen (Milk).

For Immediate Release: Allergy Alert Issued By Winter Gardens Quality Foods, Inc. for Undeclared Milk in Vodka Sauce
03/26/2020 Food Recall

Winter Gardens Quality Foods, Inc., is voluntary recalling one of its products: Whole Foods Market Vodka Sauce carrying the lot code 20057, because of an undeclared allergen (Milk).

Dr. Reddy's Laboratories Issues Voluntary Nationwide Recall of Phytonadione Injectable Emulsion USP, 10 mg/mL Single-Dose Ampules Due To Ampules Breaking And Shattering Upon Opening
03/26/2020 Medical Recall

Dr. Reddy’s Laboratories Ltd. (along with its subsidiaries together referred to as “Dr. Reddy’s”) announced today that it is voluntarily recalling four lots (ACB902, ACB903, ACB904, ACB905) of Phytonadione Injectable Emulsion USP, 10 mg/mL, Single-Dose Ampules to the hospital level. The product is b

Tiffany Food Corp. Issues Alert on Undeclared Sulfites in Huangfushanzen Dried Mushrooms
03/24/2020 Food Recall

Tiffany Food Corp. of Brooklyn, NY is recalling Huangfushanzen Huang Mountain Tea Mushroom (黄府山珍茶花菇) Dried Mushrooms with UPC 6 943153 804047 and no other coding, because it may contain undeclared sulfites

Fecal Microbiota for Transplantation: Safety Alert - Regarding Additional Safety Protections Pertaining to SARS-CoV-2 and COVID-19
03/23/2020 Medical Recall

FDA is informing health care providers and patients of the potential risk of transmission of SARS-CoV-2 virus by the use of fecal microbiota for transplantation (FMT)

Guan’s Mushroom Co Recalls Enoki Because of Possible Health Risk
03/23/2020 Food Recall

Guan’s Mushroom Co of Commerce, CA is recalling all cases of its 200g/7.05 ounce packages of Enoki Mushroom (Product of Korea) because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail

Ventilator Supply Mitigation Strategies: Letter to Health Care Providers
03/22/2020 Medical Recall

Recommendations for health care providers and facilities in treating patients who require ventilation assistance due to COVID-19 complications

Medical Glove Conservation Strategies: Letter to Health Care Providers
03/20/2020 Medical Recall

FDA recognizes that the need for personal protective equipment (PPE), such as medical gloves, may outpace the supply available to health care organizations during the Coronavirus Disease 2019 (COVID-19) outbreak.

IcelandicPlus LLC Voluntarily Recalls Whole Capelin Fish Pet Treats Because Product Exceeds FDA Size Restrictions
03/19/2020 Food Recall

Out of an abundance of caution IcelandicPlus LLC of Ft. Washington, PA, is recalling its Capelin Pet Treats because some of the fish have exceeded the FDA compliance guideline for fish larger than 5 inches. The FDA has determined that salt-cured, dried, or fermented un-eviscerated fish larger than 5

Lindt & Sprüngli (USA) Inc. Issues Voluntary Recall on Undeclared Milk and Soy in One Lot of Lindt Excellence 85% Cocoa Chocolate Bars
03/19/2020 Food Recall

Lindt & Sprüngli (USA) Inc. of Stratham, New Hampshire, is issuing a voluntary recall of one lot of its Lindt Excellence 85% Cocoa chocolate bars due to the bars being wrapped in the wrong packaging. The bars are labeled as Excellence 85% Cocoa, but contain Lindt Excellence Dark Caramel Sea Salt bar

Mountain Rose Herbs Recalls Organic Kudzu Root Herbal Supplement Due to Possible Health Risk
03/19/2020 Food Recall

Mountain Rose Herbs (MRH) of Eugene, Oregon is recalling all sizes of its Organic Kudzu Root Herbal Supplement from Lot #24247-X and #24247 because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail

CME America Recalls BodyGuard Microset Infusion Sets for the BodyGuard Infusion Pump System Due to Risk of Under-Infusion
03/18/2020 Medical Recall

CME America, a wholly owned subsidiary of Becton Dickinson, Recalls BodyGuard Microset Infusion Sets Due to Risk of Under-infusion

Chicago Indoor Garden Voluntarily Recalls Clover Sprouts and Products Containing Clover Sprouts Due To Possible Health Risk
03/16/2020 Food Recall

It has been brought to our attention by the FDA that products containing Red Clover sprouts purchased with the "Best By" dates between 12/1/19 through 3/12/20 may have been contaminated with E. coli0103. At this time no illnesses have been reported

Raw Seafoods, Inc. Issues Allergy Alert on Undeclared Wheat in Wegmans Brand Oven Safe Salmon Teriyaki and Oven Safe Ginger Salmon
03/16/2020 Food Recall

This recall is due to an undeclared wheat allergen in Wegmans branded Ginger Salmon Oven Safe Meal and Salmon Teriyaki Oven Safe Meal, which was manufactured by Raw Seafoods, Inc. for Wegmans. No illnesses or allergic reactions have been reported at this time.

Natural Remedy Store Issues Voluntary Worldwide - Recall of Active Male Due to Presence of Undeclared Tadalafil
03/16/2020 Medical Recall

Natural Remedy Store is voluntarily recalling all lots of Active Male, 500mg capsules to the consumer level. FDA analysis has found the product to be tainted with undeclared tadalafil

Cooked Butterfly Tail-On Whiteleg Shrimp (Sushi Ebi), Lot #2019.10.02
03/13/2020 Food Recall

AFC Distribution Corp. (“AFC”) of Rancho Dominguez, California is voluntary recalling Cooked Butterfly Tail-On Whiteleg Shrimp (Sushi Ebi), Lot #2019.10.02, utilized in various prepared menu offerings with sell-by dates ranging from 02/19/2020 to 03/13/2020, because this ingredient may have a potent

Winco Foods, LLC Recalls Frozen Blackberries and Frozen Berry Medley Because of Possible Health Risk
03/13/2020 Food Recall

March 13th, 2020, WinCo Foods, LLC. of Boise, ID is recalling frozen Blackberries in a 16 oz. bag and frozen Berry Medley in 16 oz. and 32 oz. bags, manufactured by Rader Farms of Lynden, WA, because both products have the potential to be contaminated with Norovirus. Norovirus is a highly contagiou

Fecal Microbiota for Transplantation: Safety Alert - Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms
03/12/2020 Medical Recall

FDA is informing health care providers and patients of the potential risk of serious or life-threatening infections with the use of fecal microbiota for transplantation (FMT)

Pero Family Farms Food Co. Issues Alert on Undeclared Egg and Milk Allergens in Zucchini Trays
03/11/2020 Food Recall

Pero Family Farms Food Company, LLC has initiated a voluntary product recall of its 11oz “Zucchini Spiral Pesto Side Dish Kit” with run number code 1196272F; Use By date of 03/20/2020 due to a product mislabeling which did not declare the allergens of egg and milk.

Surgical Mask and Gown Conservation Strategies - Letter to Healthcare Providers
03/11/2020 Medical Recall

The FDA recognizes that the need for personal protective equipment (PPE), such as surgical masks, surgical and isolation gowns, and surgical suits, may outpace the supply available to healthcare organization during the Coronavirus Disease 2019 (COVID-19) outbreak.

BD Provides Update on Feb. 4, 2020 Voluntary Recall of the BD Alaris™ System PC Units and Modules
03/10/2020 Medical Recall

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today provided an update on a previously announced voluntary recall of the BD Alaris™ System regarding software for the PC Unit and certain modules. BD has notified customers affected by this recall, and the

Voluntary Field Corrective Action of HiRes Ultra and Ultra 3D
03/10/2020 Medical Recall

Advanced Bionics (AB), a global leader in developing advanced cochlear implant systems, announced today that it has begun notifying regulatory authorities that it will voluntarily initiate a field corrective action related to the initial version of HiRes Ultra and Ultra 30 cochlear implant devices

Sun Hong Foods, Inc. Recalls Enoki Mushroom Because of Possible Health Risk
03/09/2020 Food Recall

Sun Hong Foods, Inc 1105 W Olympic Blvd, Montebello, CA 90640 is recalling All Cases Enoki Mushroom (Product of Korea) Net Wt 7.05/200g because it has the potential to be contaminated with Listeria monocytogenes

Meijer Recalls Select Mixed Nuts due to Undeclared Brazil Nuts in Product
03/09/2020 Food Recall

Meijer is initiating a voluntary recall of 13,284 packages of mixed nuts due to the potential risk of an undeclared tree-nut allergen (Brazil nuts) sold at all Meijer stores, and is being issued to its customers in cooperation with the U.S. Food & Drug Administration.

Becton Dickinson (BD) CareFusion 303 Inc. Recalls Alaris System Infusion Pumps Due to Software and System Errors
03/06/2020 Medical Recall

Recalled due to multiple system errors, software errors, and use-related errors which can lead to delay in infusion, interruption of infusion, slower than expected delivery of medication (under-infusion), and faster than expected delivery of medication (over-infusion).

Dole Fresh Vegetables, Inc. Announces Voluntary Limited Recall of H-E-B-branded Tuscan Herb Salad Kit Due to Undeclared Allergens
03/06/2020 Food Recall

This recall is due to possible undeclared allergens (peanut, wheat, soy and tree nuts) in H-E-B-branded Tuscan Herb Salad Kit, which was manufactured by Dole for H-E-B. The incorrect masterpack (kit with dressing and other toppings) was unintentionally used during the production of the salad.

Hikma Pharmaceuticals USA Inc. Extends Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP 30mg/mL, 1mL Fill/2mL Vials Due to the Potential Presence of Small Particulates
03/05/2020 Medical Recall

Hikma Pharmaceuticals PLC (Hikma, Group), today announces that its subsidiary Hikma Pharmaceuticals USA Inc. (formerly known as West-Ward Pharmaceuticals Corp.; “Hikma”) is voluntarily extending its previously-announced recall of certain lots (listed below) of Ketorolac Tromethamine Injection USP 30

Stonewall Kitchen Voluntarily Recalls a Limited Amount of Mislabeled Ghost Pepper Salsa which contains Ghost Pepper Queso
03/05/2020 Food Recall

Stonewall Kitchen of York, Maine is voluntarily recalling 4,812 jars of its Ghost Pepper Queso with an Enjoy By date of 23MAY2021, as a small number of those were mislabeled as Ghost Pepper Salsa. Ghost Pepper Queso includes two allergens, milk and soy, that are not included in Ghost Pepper Salsa, a

Singulair (montelukast) and All Montelukast Generics: Strengthened Boxed Warning - Due to Restricting Use for Allergic Rhinitis
03/04/2020 Medical Recall

FDA is strengthening existing warnings about serious behavior and mood-related changes with montelukast (Singulair and generics), which is a prescription medicine for asthma and allergy.

Vita Food Products Issues Voluntary Recall of Mislabeled Vita Wild Herring Wine Sauce Containing Undeclared Milk
03/04/2020 Food Recall

Vita Food Products, Inc. of Chicago, Illinois is notifying the public that it is recalling up to 8,376 individual plastic jars of 32 ounce Vita Wild Herring in Wine Sauce that are potentially mislabeled because they may contain sour cream and, therefore, may contain undeclared milk.

New Capstone, Inc. Issues Allergy Alert on Restructure Vanilla Protein Powder Due to Undeclared Milk
03/03/2020 Food Recall

New Capstone, Inc. of Mooresville, NC is recalling their 22oz ReStructure Vanilla Protein Powder pouches, Lot 19211 Exp. 06/21 and their 27 gram individual serving pouch, Lot 19211 Exp. 06/21, because they may contain undeclared milk.

Allergy Alert Issued for Undeclared Milk in Green Chile Chicken Tamales Sold at Whole Foods Market Stores in Multiple States
03/03/2020 Food Recall

Whole Foods Market is voluntarily recalling select Green Chile Chicken Tamales from stores across 24 states because they contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

SweynTooth Cybersecurity Vulnerabilities May Affect Certain Medical Devices: FDA Safety Communication
03/03/2020 Medical Recall

Learn about the SweynTooth cybersecurity vulnerabilities associated with Bluetooth Low Energy (BLE) and recommendations for patients, health care providers, and manufacturers.

Purina Animal Nutrition Voluntarily Recalling Select Lot Codes of Purina®Rabbit Feed, Purina® Turkey Feed, Country Acres® Rabbit Feed and DuMOR® Chick Starter/Grower Feed
02/28/2020 Food Recall

Purina Animal Nutrition is initiating a voluntary recall of multiple lots of Purina® Rabbit Feed, Purina® Turkey Feed, Country Acres® Rabbit Feed and DuMOR® Chick Starter/Grower Feed due to elevated calcium levels in the product.

King Systems Recalls King Vision Video Laryngoscope Adapter Size ½ Due to a Display of The Reversed Image
02/27/2020 Medical Recall

The device shows an image on the display while examining a patient’s upper airway. A reverse image is displayed which could cause potential injury.

Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories: FDA Safety Communication
02/27/2020 Medical Recall

The FDA wants to make consumers and health care providers aware that, to date, the FDA has not authorized for market any products using ozone gas or ultraviolet (UV) light to clean, disinfect, or sanitize continuous positive airway pressure (CPAP) devices and accessories.

American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP 150 mg, 100 Count Unit Dose Blisters Due to the Detection of N-nitrosodimethylamine (NDMA) Impurity
02/27/2020 Medical Recall

American Health Packaging has voluntarily recalled eleven (11) lots of Ranitidine Tablets, USP 150 mg, 100 count Unit Dose Blisters to the consumer level due to the potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

Choice Products USA, LLC Issues an Allergy Alert on Undeclared Milk in Premier Choice 3 lb. Tub Peanut Butter Cookie Dough Ordered Through Online Ordering
02/26/2020 Food Recall

Choice Products USA, LLC of Eau Claire, WI, is recalling 275 - 3lb tubs of Peanut Butter Cookie Dough, because it may contain undeclared milk from milk chocolate chips. People who have an allergy or severe sensitivity to milk run the risk of allergic reaction if they consume these products.

UPDATE: Reduce the Risk of Cardiac Surgery Infection While Using the LivaNova Heater-Cooler System 3T: FDA Safety Communication
02/25/2020 Medical Recall

FDA reminds health care providers and staff of actions to take to reduce the risk of cardiac surgery infection when using the LivaNova Heater-Cooler System 3T.

UPDATE: The FDA recommends performing contained morcellation in women when laparoscopic power morcellation is appropriate
02/25/2020 Medical Recall

The U.S. Food and Drug Administration (FDA) is updating our 2014 safety communication on laparoscopic power morcellators to provide new information on the safe and effective use of laparoscopic power morcellation for gynecologic procedures.

Tytek Medical Recalls TM-317 PneumoDart-Pneumothorax Needle Due to Fully and Partially Blocked Needles
02/25/2020 Medical Recall

The needle is used to remove air from the lung cavity. If the needle is blocked, emergency treatment is delayed which can lead to heart or lung failure.

Sierra Soups Issues Allergy Alert on Undeclared Gluten in “Pasta e Fagioli” Soup
02/25/2020 Food Recall

Sierra Soups of Fresno, Ca is recalling its 13 ounce packages of "Pasta e Fagioli" because the soup mix contains an individually wrapped package of pasta, which contains gluten

Med Man Expands Voluntary Nationwide Recall of Up2 and Bow & Arrow Due to Presence of Undeclared Sildenafil
02/24/2020 Food Recall

On 11/8/2019, Med Man Distribution voluntarily recalled all lots of Up2 dietary supplement. The recall has expanded to include all lots of dietary supplement Bow and Arrow libido enhancer for men to the consumer level.

Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Phenytoin Oral Suspension Usp, 125 Mg/5 Ml due to Possible Underdosing or Overdosing
02/21/2020 Medical Recall

Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling two (2) lots of Phenytoin Oral Suspension USP, 125 mg/5 mL both in 237 mL bottles, to the consumer level. Phenytoin Oral Suspension USP, 125 mg/5 mL is indicated for the treatment of tonic-clonic (grand mal) and psy

Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Phenytoin Oral Suspension USP, 125 mg/5ml Due to Possible Underdosing or Overdosing
02/21/2020 Medical Recall

Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling two (2) lots of Phenytoin Oral Suspension USP, 125 mg/5 mL both in 237 mL bottles, to the consumer level. Phenytoin Oral Suspension USP, 125 mg/5 mL is indicated for the treatment of tonic-clonic (grand mal) and psy

Moonstruck Chocolate Issues Allergy Alert on Undeclared Milk in 3.1 oz. Praline Pecan & Ginger Element Bar in Dark Chocolate
02/21/2020 Food Recall

Moonstruck Chocolate Co. of Portland, Oregon is recalling 1,500 / 3.1 oz. Praline Pecan & Ginger Element Bar in Dark Chocolate, because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they

Abbott Initiates Voluntary Recall of Specific Lots of Two Coronary Catheters
02/20/2020 Medical Recall

Abbott has voluntarily recalled specific lots of two catheters used in coronary angioplasty procedures: the NC Trek RX Coronary Dilatation Catheter and the NC Traveler Coronary Dilatation Catheter, balloon diameters 4.0mm, 4.5mm and 5.0mm. This recall does not affect patients who have successfully u

Natural Grocers Issues Recall on Dark Chocolate Peanut Clusters
02/20/2020 Food Recall

. Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery chain, is recalling Natural Grocers brand 8 ounce Peanut Clusters Dark Chocolate Non-GMO because the product contains undeclared almond allergen. People who have an allergy or severe sensitivity to almonds run

Natural Grocers Issues Recall on Dark Chocolate Almond Clusters
02/20/2020 Food Recall

Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery chain, is recalling Natural Grocers brand 8 ounce Almond Clusters Dark Chocolate Non-GMO because the product contains undeclared peanut allergen. People who have an allergy or severe sensitivity to peanuts run the

Teleflex Medical Recalls Comfort Flo Humidification Systems Due to Malfunction That May Cause Water to Enter Airway
02/19/2020 Medical Recall

The system provides heated and humidified breathing gases to patients. The system may malfunction causing water to enter the airway causing serious injury.

ResMed Recalls Stellar 100 and 150 Non-invasive and Invasive Ventilators Due to Sound Alarm Failure
02/19/2020 Medical Recall

The ventilators are used on patients that need breathing support. The sound alarm on the ventilator may fail to alert, presenting a risk of injury or death.

Abbott Vascular Recalls NC Trek RX and NC Traveler RX Coronary Dilatation Catheters Due to Failure of Balloon (diameter 4.0mm, 4.5mm and 5.00mm) to Deflate
02/19/2020 Medical Recall

Coronary dilation catheters are used to open clogged blood vessels to improve blood flow to the heart, Abbot is recalling these devices due to failure of balloon to deflate in certain models, use may cause serious adverse health consequences, such as reduced blow flow to the heart and air embolism.

Saratoga Potato Chips, LLC Issues Allergy Alert on Undeclared Milk in Kroger Sweet & Mesquite BBQ Potato Chips
02/19/2020 Food Recall

Saratoga Potato Chips, LLC of Fort Wayne, Indiana is recalling 140 cases of Kroger Sweet & Mesquite BBQ Potato Chips because it may contain undeclared milk

CJ Foods Voluntarily Recalls Annie Chun’s Japanese-Style Teriyaki Noodle Bowls Due To Undeclared Peanuts
02/14/2020 Food Recall

CJ Foods, Inc., a division of CJ America, Inc., of La Palma, CA, is voluntarily recalling Annie Chun’s Japanese-Style Teriyaki Noodle Bowls because it may contain undeclared peanuts. Use of this product may cause serious allergic reaction or illness in people who have an allergy or severe sensitivit

Gourmet International and Butlers Chocolates Issue Allergy Alert on Undeclared Milk in Butlers Irish Whiskey Dark Chocolate 3.5 oz Tablet Bar
02/13/2020 Food Recall

Are recalling approximately 1900 units of the IRISH WHISKEY DARK CHOCOLATE 3.5OZ TABLET BAR because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious allergic reaction or illness if they consume these products.

Hubbard Feeds Voluntarily Recalls Easy Feed Products and Organic Ground Flaxseed ORG
02/13/2020 Food Recall

Hubbard Feeds is voluntarily recalling products as the result of an ingredient-supplier recall. The supplied ingredient contained residue of an unapproved herbicide (Haloxyfop).

Belviq, Belviq XR (lorcaserin) by Eisai: Drug Safety Communication - FDA Requests Withdrawal of Weight-Loss Drug
02/13/2020 Medical Recall

FDA has requested that the manufacturer voluntarily withdraw the weight-loss drug from the U.S. market because a safety clinical trial shows an increased occurrence of cancer. The drug manufacturer, Eisai Inc,. has submitted a request to voluntarily withdraw the drug.

Save A Lot Issues Allergy Alert on Undeclared Peanuts in Coburn Farms 4.5oz Sharp Yellow Cheddar Cheese, Cherry Juice-Infused Dried Cranberries & Roasted Sea Salted Cashews Snackers
02/13/2020 Food Recall

Save A Lot is recalling 131 cases of Coburn Farms 4.5oz Sharp Yellow Cheddar Cheese, Cherry Juice- Infused Dried Cranberries & Roasted Sea Salted Cashews Snackers due to a labeling error leading to undeclared peanut allergens in Snackers packages manufactured by Great Lakes Cheese Co. Inc., headquar

Medtronic Recalls MiniMed Insulin Pumps for Incorrect Insulin Dosing
02/12/2020 Medical Recall

Missing or broken retainer ring could cause under or over delivery of insulin. This may cause patient injury or death.

Voluntary Recall Notice of Sunny Select Au Jus Gravy Mix 1 oz Pouches Due to Unlabeled Dairy Allergen
02/11/2020 Food Recall

McCormick & Company, Inc. is initiating a voluntary recall of Sunny Select Au Jus Gravy Mix 1 oz pouches due to an unlabeled dairy allergen.

Lotte Int’l America Corp Issues Allergy Alert on Undeclared Almonds in Chocopies
02/11/2020 Food Recall

Lotte Int’l America Corp is recalling its 11.85-ounce packages of “Chocopie” manufactured by Lotte Confectionery Co. Ltd. Korea because of findings of small amount of almond in the product and packaging shows the “manufactured in a facility that also processes peanut & almond”.

Blendtopia Products, LLC Voluntarily Recalls Frozen Smoothie Products Due to Possible Health Risk
02/11/2020 Food Recall

Blendtopia Products, LLC is voluntarily recalling 29,078 cases of 7 ounce frozen Blendtopia brand superfood Smoothie Kits because of potential contamination with Listeria monocytogenes.

Missa Bay LLC Issues Allergy Alert and Recall on Mislabeled Salad Product
02/11/2020 Food Recall

Missa Bay LLC of Swedesboro, N.J. is recalling 1,154 cases of Ready PacⓇ BistroⓇ Bowl Spinach Dijon Salad due to a labeling error leading to the potential for undeclared egg and wheat allergens on a limited number of the salads. The salads contain eggs and wheat, which, while visible through the pac

Corinthian Foods Recall 5 Lb Bags of Uncooked Sweet Potato Crusted Alaska Nuggets 1 Oz. Due to Mislabeling
02/09/2020 Food Recall

Corinthian Trading, Inc./DBA Corinthian Foods is recalling 5 lb. retail bags of Uncooked Sweet Potato Crusted Alaska Pollack Nuggets 1 oz. with date code CF35319 due to mislabeling. The bag contains Chicken Nuggets instead of Fish Nuggets. The product is packaged in clear 5 lb. bags with a white

Nuts ‘N More LLC. Recalls: Plain Peanut Spread Because Of Possible Health Risk
02/07/2020 Food Recall

Nuts ‘N More of East Providence, RI. is recalling 4143 jars of plain Peanut Spread because it has the potential to be contaminated with Listeria species and to protect the public from a potential health hazard.

GE Healthcare Recalls Carestation 600 Series Anesthesia Systems Due to Loss of Mechanical Ventilation
02/07/2020 Medical Recall

A loose cable connection could cause the loss of mechanical ventilation which could lead to serious injury or death.

New Seasons Market Recalls Grab N’ Go Vegetarian Lasagna w/Gluten Free Pasta Due to Undeclared Soy
02/06/2020 Food Recall

This product is being voluntarily recalled due to the presence of an undeclared allergen (soy). Customers who purchased this product and are allergic to soy are urged to not consume it.

Cargill Conducts Voluntary Recall of a Single Lot of Nutrebeef® Transition Pellet Due to Elevated Levels of Monesin
02/04/2020 Food Recall

Cargill’s animal nutrition business is conducting a voluntary recall of a single lot (382 bags, 50 lb each) of NutreBeef® Transition Pellet (MH) beef cattle feed because the product may contain mispackaged feed with elevated levels of monensin

GE Healthcare Recalls CARESCAPE Respiratory Modules Due to Incorrect Oxygen Values
02/04/2020 Medical Recall

A manufacturing problem could cause the displayed oxygen values to be incorrect which could lead to serious injury or death.

Allergy Alert Issued for Undeclared Milk in Bundt Cake and Chocolate Dipped Cookies Sold at 44 Whole Foods Market Stores in the Mid-Atlantic Region
02/04/2020 Food Recall

Whole Foods Market is voluntarily recalling select bundt cakes and chocolate dipped cookies from stores in Kentucky, Maryland, New Jersey, Pennsylvania, Ohio, Virginia and Washington D.C. because they contain undeclared milk.
People who have an allergy or severe sensitivity to milk run the risk of

Salud Natural Entrepreneur Inc. Recalls Nopalina Flax Seed Fiber Powder and Nopalina Flax Seed Fiber Capsules Because of Possible Health Risk (Updated Lot Number Information)
01/31/2020 Food Recall

Nopalina Flax Seed Fiber (powder) and Nopalina Flax Seed Fiber (capsule) products due to possible Salmonella contamination in one of the ingredients used on the formula of Nopalina Flax Seed Fiber.

Efficient Laboratories, Inc. Issues Voluntary Nationwide Recall of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAX due to Microbial Contamination
01/31/2020 Medical Recall

Efficient Laboratories, Inc. is voluntarily recalling one lot each of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAXliquid. Specifically, we are recalling the following lots: Rompe Pecho EX lot 19F332, exp June 2022, Rompe Pecho CF lot 19H359, exp August 2022 and Rompe Pecho MAX lot 19B42, ex

Cybersecurity Vulnerabilities Affecting Medtronic Implantable Cardiac Devices, Programmers, and Home Monitors: FDA Safety Communication
01/30/2020 Medical Recall

Regarding cybersecurity vulnerabilities identified in a wireless telemetry technology used for communication between Medtronic’s implantable cardiac devices, clinic programmers, and home monitors.

Bakkavor Foods USA, Inc. Issues Allergy Alert on Undeclared Milk in Mushroom Barley Soup
01/29/2020 Food Recall

Bakkavor Foods USA, Inc. is voluntarily recalling 840 units of Harris Teeter’s Fresh Food Market Mushroom Barley Soup, 16 oz with “SELL BY” date codes 03/09/20 because it may contain undeclared milk.

2020 Medical Device Recalls
01/29/2020 Medical Recall

List of Medical Device recalls in 2020.

Beepa’s Issues Allergy Alert in Undeclared Milk in Product
01/29/2020 Food Recall

Beepa’s of Beloit, WI is recalling Goulash, because it may contain undeclared milk

Clozaril, Fazaclo ODT, Versacloz (clozapine): Drug Safety Communication - FDA Strengthens Warning That Untreated Constipation Can Lead to Serious Bowel Problems
01/28/2020 Medical Recall

FDA is strengthening an existing warning that constipation caused by the schizophrenia medicine clozapine (Clozaril, Fazaclo ODT, Versacloz, generics) can, uncommonly, progress to serious bowel complications. This can lead to hospitalization or even death if constipation is not diagnosed/treated.

Distributor Teleflex Recalls the Galemed Babi.Plus Pressure Relief Manifolds Due to Dislodged Valve
01/28/2020 Medical Recall

The Babi.Plus Pressure Relief Manifold is used as part of a breathing circuit to assist infant patients to breathe. This device is being recalled due to a dislodged valve resulting in loss of pressure in the system. Teleflex issued a Medical Device Recall Notice to affected customers.

Salud Natural Entrepreneur Inc. Recalls Nopalina Flax Seed Fiber Powder and Nopalina Flax Seed Fiber Capsules Because of Possible Health Risk
01/28/2020 Food Recall

Salud Natural Entrepreneur, Inc. of Waukegan, IL is voluntarily recalling Nopalina Flax Seed Fiber (powder) and Nopalina Flax Seed Fiber (capsule) products due to possible Salmonella contamination

King Systems Issues Recall of King Vision Video Laryngoscope Video Adapter Size 1/2
01/24/2020 Medical Recall

King Systems initiated a voluntary recall of One-Hundred Seventy-One (171) units of its King Vision Video Laryngoscope Adapter Size 1/2. The affected products have been found to exhibit a reversed image, which could potentially result in difficulty navigating during intubation and/or delay in intub

Quesos La Ricura LTD. Recalls Cotija Cheese (Queso Cotija) Because Of Possible Health Risk
01/24/2020 Food Recall

Quesos La Ricura LTD. of Hicksville, NY, is recalling 12 oz. packages of Cotija Cheese (Queso Cotija) because it may be contaminated with Shiga toxin producing E. coli bacteria (Shiga toxin producing E. coli).

2020 Safety Communications
01/23/2020 Medical Recall

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.

Cybersecurity Vulnerabilities in Certain GE Healthcare Clinical Information Central Stations and Telemetry Servers: Safety Communication
01/23/2020 Medical Recall

FDA is informing health care providers and facility staff about cybersecurity vulnerabilities that may introduce risks to patients while being monitored using certain GE Healthcare Clinical Information Central Stations and Telemetry Servers.

Lipari Foods Issues Voluntary Recall Expansion on Additional Sandwiches Due to Potential Contamination of Listeria Monocytogenes
01/22/2020 Food Recall

Lipari Foods is expanding its January 6, 2020 and January 13, 2020 recalls of Premo and Fresh Grab sandwiches to include all sandwiches with a Best By date of 2/6/20 and prior, due to potential contamination of Listeria monocytogenes

ABH NATURE’S PRODUCTS, INC, ABH PHARMA, INC., and STOCKNUTRA.COM, INC. Issues Nationwide Recall of All Lots of Dietary Supplement Products
01/22/2020 Food Recall

This recall applies to all dietary supplement products manufactured and sold between January 2013 – November 2019 and all lots of products are included in this recall. These products are being recalled after an FDA inspection found significant violations of current good manufacturing practice regula

Five Star Food Recalls Sham Gardens Excellent Tahina Because of Possible Health Risk
01/21/2020 Food Recall

Five Star Food Inc, Garden City, MI is recalling 100 cases of Excellent tahina 800 g and 100 cases of excellent tahina 400 g containers because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or eld

Savannah Food Company, Inc. Voluntarily Recalls Cornbread Dressing and Bread Stuffing Products Due to Possible Health Risk
01/21/2020 Food Recall

Products that contained frozen diced eggs from Almark Foods have the potential to be contaminated with Listeria monocytogenes

Yes To Inc. Issues Voluntary Recall of Product Due to Skin Irritation Complaints ‘Grapefruit Vitamin C Glow Boosting Unicorn Paper Mask’
01/17/2020 Food Recall

Yes To Inc. has issued a voluntary recall of all lots of its Grapefruit Vitamin C Glow-Boosting Unicorn Paper Mask in response to complaints of skin irritation and redness.

Surgical Gowns and Packs by Cardinal Health: FDA Statement - Potential Quality Issues Affecting Some of its Level 3 Surgical Gowns and Accompanying PreSource Procedural Packs
01/16/2020 Medical Recall

The medical device manufacturer Cardinal Health alerted its customers to potential quality issues affecting some of its Level 3 surgical gowns and accompanying PreSource procedural packs.

FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical Issues Voluntary Nationwide Recall of All Sterile Drug Products Within Expiry Due to A Lack of Assurance of Sterility
01/16/2020 Medical Recall

FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical is voluntarily recalling all unused sterile drug products within expiry, to the user level, due to a lack of assurance of sterility. The recalled sterile products have been found to be inconsistent with federal guidelines.

The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication
01/15/2020 Medical Recall

FDA is sharing recommendations and updates to help improve duodenoscope reprocessing.

Belviq, Belviq XR (lorcaserin): Drug Safety Communication - Due to Possible Increased Risk of Cancer
01/14/2020 Medical Recall

FDA is alerting the public that results from a clinical trial assessing safety show a possible increased risk of cancer with the weight management medicine Belviq, Belviq XR (lorcaserin).

Lipari Foods Issues Recall of Various Wedge Deli Sandwiches Due to Potential Contamination of Listeria Monocytogenes
01/13/2020 Food Recall

Lipari Foods has issued a voluntary recall of various Premo and Fresh Grab wedge sandwiches due to potential contamination of Listeria monocytogenes.

Lipari Foods Issues Voluntary Recall Expansion on Additional Sandwiches Due to Potential Contamination of Listeria Monocytogenes
01/13/2020 Food Recall

Lipari Foods has issued a voluntary recall expansion of additional Premo and Fresh Grab sandwiches due to potential contamination of Listeria monocytogenes.

Taro Pharmaceuticals U.S.A., Inc. Issues Voluntary Nationwide Recall of Lamotrigine Tablets USP, 100 mg, 100 Count Bottles
01/10/2020 Medical Recall

Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling one (1) lot of Lamotrigine 100 mg Tablets, Lot # 331771 (expiration date June 2021) in 100 count bottles, NDC 51672-4131-1 to the consumer level.

Stryker Launches Voluntary Field Action for Specific Units of The LIFEPAK® 15 Monitor/Defibrillator
01/10/2020 Medical Recall

Stryker announced today that the company is launching a voluntary field action on specific units of the LIFEPAK 15 monitor/defibrillators.

Fresh Location Announces Product Recall Due to Possible Listeria Contamination
01/08/2020 Food Recall

Protein Snack Tray 6.44 oz total weight packaged in a 4-compartment plastic tray with UPC: 8-5511000804-6 and with Fresh by lot dates of: 12/21/19, 12/22/19, 12/24/19, 12/27/19, 12/28/19, 12/29/19, 12/31/19, 01/03/20, 01/04/20. Protein Trail Mix 3.52 oz total weight packaged in a 10.5 ounce pla

Mavidon Issues Voluntary Worldwide Recall of Manufactured Products Including Lemonprep® Tubes And Single Use Cups Pediaprep® Tubes And Single Use Cups Wave Prep® Tubes And Single Use Cups Cardio Prep Single Use Cups Due To Burkholderia Cepacia Contaminati
01/08/2020 Medical Recall

Mavidon is voluntarily recalling all lots of products manufactured at our facility including LemonPrep®, PediaPrep® and Wave Prep 4-ounce tubes and single use cups, Cardio Prep and Collodions, Collodion removers due to contamination with Burkholderia cepacia.

Denton Pharma, Inc. dba Northwind Pharmaceuticals Voluntarily Recalls All Unexpired Lots of its Ranitidine Tablets and Ceases Distribution, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity
01/08/2020 Medical Recall

Denton Pharma, Inc. dba Northwind Pharmaceuticals, an affiliate of Northwind Pharmaceuticals, LLC (“Northwind”) today announced the voluntary recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300mg, to the consumer level. The recall is in response to the manufacturer’s recall of all un

Mylan Initiates Voluntary Nationwide Recall of Three Lots of Nizatidine Capsules, USP, Due to the Detection of Trace Amounts of NDMA (N-Nitrosodimethylamine) Impurity Found in the Active Pharmaceutical Ingredient Manufactured by Solara Active Pharma Scien
01/08/2020 Medical Recall

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall, to the consumer level, of three lots of Nizatidine Capsules, USP (including the 150mg and 300mg strengths). While Mylan has not received any reports of adverse eve

Jeni’s Splendid Ice Creams Issues Voluntary Recall of Cold Brew with Coconut Cream
01/07/2020 Food Recall

Jeni’s Splendid Ice Creams has initiated a voluntary recall of three batches of Cold Brew with Coconut Cream Non-Dairy Frozen Dessert pints because they may contain an undeclared milk allergen

Appco Pharma LLC Issues Voluntary Nationwide Recall of Ranitidine Hydrochloride Capsules 150 mg and 300 mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)
01/07/2020 Medical Recall

Appco Pharma LLC (Appco) is voluntarily recalling all quantities and lots, within expiry, of Ranitidine Hydrochloride Capsules to the Consumer level. Ranitidine Hydrochloride Capsules are being recalled because of the presence or potential presence of N-nitrosodimethylamine (NDMA)

Purely Elizabeth Recalls Pouches of Chocolate Sea Salt Probiotic Granola Recall Due to a Mislabeling Error That Has Resulted in an Undeclared Allergen
01/06/2020 Food Recall

Purely Elizabeth is initiating a voluntary recall of their Chocolate Sea Salt Probiotic granola due to a mislabeling error that has resulted in an undeclared allergen (walnuts) being present.

Ducktrap River of Maine Recalls One Lot of Herring Center Cuts in Wine Sauce Due to Undeclared Dairy in Product
01/05/2020 Food Recall

Ducktrap River of Maine of Belfast, Maine is announcing a voluntary recall of Herring Center Cuts in Wine Sauce identified with sell by date Jul 29, 2020 because these products contain undeclared milk due to an incorrect label.

Cargill Voluntarily Recalls 39 One-Pound Bags of Product Packaged as Wilbur Dark Chocolate Covered Cashews Wheat Allergen Presence
01/03/2020 Food Recall

Cargill is voluntarily recalling 39 one-pound bags of product incorrectly packaged as Wilbur Dark Chocolate Covered Cashews. Sold locally through the Wilbur Chocolate Store in Lititz, Penn., the bags are being recalled out of an abundance of caution because of a wheat allergen presence. Wilbur Dark

Limena, LLC Recalls "Salvadorean String Cheese (Quesillo Cheese)" Because of Possible Health Risk
01/03/2020 Food Recall

Limena, LLC of Palm Springs, FL. is recalling its 1 lb. (16 ounce) blocks of Salvadorean String Cheese (Quesillo Cheese) semi-soft cheese because it has the potential to be contaminated with Listeria monocytogenes

FiveStar Gourmet Foods Voluntary Recalls Fresh Snack Products Due to Possible Health Risk
01/02/2020 Food Recall

FiveStar Gourmet Foods takes issues of food safety seriously and in an abundance of caution is voluntarily recalling two fresh produce snack products, MiniMeal2Go-ProteinPack 8.25oz and MiniMeal2Go- AvocadoToast 6.75oz. due to the notification from Almark Foods of Gainesville, GA that Almark Foods m

Dianne's Fine Desserts Issues Allergy Alert on Undeclared Peanut Allergen in Product Sienna Turtle Brownie Item Number 8495241115 Lot Code 19198
01/01/2020 Food Recall

Dianne's Fine Desserts of Newburyport, MA 01950 is recalling twenty six cases of product Sienna Turtle Brownie 8495241115 lot code 19198 , because it may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reac

Meijer Recalls Diced Hard Boiled Eggs Due to Potential Health Risks Product Bought at Two Stores in Grand Rapids Affected
01/01/2020 Food Recall

As part of a multi-state recall due to the potential risk of Listeria monocytogenes, Meijer – in conjunction with Almark Foods - is announcing a voluntary recall of frozen hard-boiled egg products used on two salad bars at two stores in Grand Rapids, Mich.

Aurobindo Pharma USA, Inc. Issues Voluntary Nationwide Recall of Mirtazapine Tablets Lot Number 03119002A3 Due to Label Error on Declared Strength
12/31/2019 Medical Recall

Aurobindo Pharma USA, Inc. is voluntarily recalling lot number 03119002A3 of Mirtazapine Tablets to the consumer level. The product is being recalled due to a label error on declared strength; bottles labeled as Mirtazapine 7.5 mg may contain 15 mg tablets.

Veggie Noodle Co. Recalls Cece’s Brand Product Because of Possible Health Risk
12/29/2019 Food Recall

Veggie Noodle Co., LLC is voluntarily recalling its Cece’s® Veggie Co. brand Fresh Veggie Ramen with Chicken Broth, all expiration dates, sold at retail stores nationally, because the separately packaged egg that is included in the product has the potential to be contaminated with Listeria

Sprouts Unlimited Inc. is Recalling Clover Sprouts in 4-ounce Packages Due to a Possible Health Risk
12/27/2019 Food Recall

Sprouts Unlimited of Marion IA is recalling clover spouts in 4 oz packages because it may be contaminated with Escherichia coli O103 bacteria

Great American Deli Announces Product Recall Due to Possible Listeria Contamination
12/26/2019 Food Recall

Great American Deli of Ooltewah, Tennessee is recalling GAD #114 Egg Salad Sandwich 4.8 oz. UPC: 7-41431-00114-2 due to possible contamination of Listeria monocytogenes

Reichel Foods Inc. Recalls Egg-containing Products Because of Possible Health Risk
12/26/2019 Food Recall

Out of an abundance of caution, Reichel Foods Inc. is voluntarily recalling Pro2Snax To The Max Granny Apples /Hard Boiled Egg/Cheddar/Cashew & Craisin and Pro2Snax To The Max Gala Apples/Hard Boiled Egg/White Cheddar/Almond & Craisin.

Dierbergs Markets Recalls Egg-containing Products Because of Possible Health Risk
12/25/2019 Food Recall

Due to a recent recall by Almark, an ingredient supplier, and out of an abundance of caution for safety of our customers St. Louis based Dierbergs Markets is recalling various products in all 25 retail stores.

Almark Foods Expanded Recall to all Products from its Georgia Facility Due to Possible Listeria monocytogenes Contamination
12/24/2019 Food Recall

Almark Foods is expanding its voluntary recall to include all hard-boiled eggs manufactured at the firm’s Gainesville, Georgia facility, including all retail, pillow pack, pouch pack, frozen diced, and protein kit products, , due to potential contamination with Listeria monocytogenes.

Bakkavor Foods USA, Inc. Issues Voluntary Recall of Trader Joe’s Egg Salad and Potato Salad Because of Possible Health Risks
12/24/2019 Food Recall

Bakkavor Foods USA, Inc. is voluntarily recalling Trader Joe’s Egg Salad, 6 oz and Trader Joe’s Old Fashioned Potato Salad, 20 oz with “USE BY” date codes up through and including 12/27/19 because these products have the potential to be contaminated with Listeria monocytogenes.

Mavidon Issues Voluntary Worldwide Recall of all Manufactured Products Due to Burkholderia cepacia Contamination
12/23/2019 Medical Recall

Mavidon is voluntarily recalling all lots of products manufactured at our facility including LemonPrep®, PediaPrep® and Wave Prep 4-ounce tubes and single use cups, Cardio Prep and Collodions, Collodion removers due to contamination with Burkholderia cepacia.

Almark Foods Recalls Hard Cooked Egg Products in Pails Due to Possible Listeria Monocytogenes Contamination.
12/20/2019 Food Recall

Almark Foods is voluntary recalling Hard-Boiled and Peeled Eggs in white plastic pails with white plastic lids due to the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or

Emesa Foods Recalls Premium Sesame Tahini Because of Possible Health Risk
12/20/2019 Food Recall

Emesa Foods, Taylor, MI is voluntarily recalling 23 cases and each case 6 containers of 800 gram of “Premium Sesame Tahini” because it has the potential to be contaminated with Salmonella.

Allergy Alert Issued Due to Undeclared Milk or Coconut in 365 Everyday Value Dark Chocolate Sandwich Cremes
12/20/2019 Food Recall

Whole Foods Market is voluntarily recalling 365 Everyday Value Dark Chocolate Peppermint Sandwich Cremes and 365 Everyday Value Dark Chocolate Caramel Sea Salt Sandwich Cremes because the products may contain undeclared milk or tree nuts (coconut).

LivaNova Recalls VNS Therapy SenTiva Generator Due to Reset Error
12/20/2019 Medical Recall

LivaNova is recalling the VNS Therapy SenTiva Generator System due to an unintended reset error that causes the system to stop delivering VNS therapy.

Neurontin, Gralise, Horizant (gabapentin) and Lyrica, Lyrica CR (pregabalin): Drug Safety Communication - Serious Breathing Problems
12/19/2019 Medical Recall

FDA is warning that serious breathing difficulties may occur in patients using gabapentin or pregabalin who have respiratory risk factors.

Smiths Medical ASD, Inc. Recalls Medfusion® 4000 Syringe Pumps Due to Malfunctioning Alarms and Potential Interruption of Therapy
12/19/2019 Medical Recall

The software updates could cause alarms to stop working and cause the battery to drain without warning and potentially interrupt therapy, which could lead to serious injury or death.

Lannett Issues Voluntary Nationwide Recall Of Levetiracetam Oral Solution, 100mg/Ml Due To Microbial Contamination
12/18/2019 Medical Recall

Lannett Company, Inc. today announced that it is voluntarily recalling two (2) lots of Levetiracetam Oral Solution, 100mg/mL to the consumer level due to contamination with Bacillus subtilis. The Bacillus subtilis was identified during an evaluation of a raw material used to manufacture the product

GE Healthcare Recalls Giraffe Incubators and OmniBeds Due to Potential for Infants to Fall
12/17/2019 Medical Recall

The bedside panels and portholes can appear closed without being latched, no longer protect the infant from falling.

Glenmark Pharmaceuticals Inc., USA Voluntarily Recalls All Unexpired Lots of its Ranitidine Tablets and Ceases Distribution, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity
12/17/2019 Medical Recall

Glenmark Pharmaceutical Inc., USA (“Glenmark”) today announced the voluntary recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300 mg, to the consumer level.

Motto International Corp. Issues Voluntary Recall of Bull Platinum 30000, Stallion Platinum 30000, Rhino 7 Platinum 30000, and Panther Platinum 30000, Due to Presence of Undeclared Tadalafil
12/17/2019 Medical Recall

Motto International Corp. is voluntarily recalling all lots of Bull Platinum 30000, Stallion Platinum 30000, Rhino 7 Platinum 30000, and Panther Platinum 30000, to the consumer level.

Cook Medical Recalls CrossCath® Support Catheters Due to a Manufacturing Error Which May Cause the Marker Bands to Dislodge or Cause Buckling
12/17/2019 Medical Recall

FDA classifies Class I recall for Cook Medical CrossCath® Support Catheters due to radiopaque marker bands being too loose or too tight on certain catheters.

Medtronic Recalls SynchroMed II Implantable Drug Infusion Pump Due to the Potential Presence of Foreign Particles Inside the Pump Motor Assembly Which May Lead to a Pump Motor Stall
12/13/2019 Medical Recall

Medtronic received reports of early permanent motor stall due to the presence of foreign particles. Permanent motor stall could lead to serious injury or death.

CATSMO LLC. Recalls Smoked Salmon Because of Possible Health Risk
12/11/2019 Food Recall

CATSMO LLC. Of Wallkill, NY, out of an abundance of caution, is recalling Cold Smoked Salmon because it has the potential to be contaminated with Listeria monocytogenes.

TDBBS Voluntarily Recalls Pig Ear Pet Treats No Illnesses Report, Strictly Precautionary xxxx
12/09/2019 Food Recall

“This recall has been initiated due to possible Salmonella contamination, which poses a health risk. It is important to know that no illnesses have been reported, and the amount of affected product is minimal.

Public Safety Alert Due to Marketing of Unapproved Stem Cell and Exosome Products
12/09/2019 Medical Recall

FDA is informing the public, especially patients, health care practitioners, and clinics, of multiple recent reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes.

Public Safety Alert Due to Marketing of Unapproved Stem Cell and Exosome Products
12/09/2019 Medical Recall

FDA is informing the public, especially patients, health care practitioners, and clinics, of multiple recent reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes.

Tailor Cut Produce Recalls Cut Fruit Mix Because of Possible Health Risk
12/08/2019 Food Recall

Tailor Cut Produce of New Jersey, is recalling its Fruit luau, cut honeydew, cut cantaloupe and cut pineapple products because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people.

Tropical Nut and Fruit Co. Issues Allergy Alert of Undeclared Soy and Tree Nut (Almonds) on Their Truly Good Foods South of the Border Mix
12/07/2019 Food Recall

Charlotte headquartered Tropical Nut and Fruit Co. is voluntarily recalling their 25lb box of Truly Good Foods South of the Border nut mix, Lot #29119, best by date 04/15/2020, item # 102340 and UPC # 094184110198 because it contains undeclared soy and tree nut (al-monds).

White Castle Frozen Food Division Announces Voluntary Recall of a Limited Production of Frozen Sandwiches Sold in Select Grocery Outlets Due to Possible Presence of Listeria Monocytogenes
12/07/2019 Food Recall

White Castle has initiated a voluntary recall of a limited number of frozen 6 pack cheeseburgers, frozen 6 pack hamburgers, frozen 6 pack jalapeno cheeseburgers, and 16 pack hamburgers, 16 pack cheeseburgers for the possible presence of Listeria monocytogenes.

The J. M. Smucker Company Issues Voluntary Recall of Specific Lots of Special Kitty® Wet, Canned Cat Food Due to Health Concerns
12/05/2019 Food Recall

The J. M. Smucker Company today announced a voluntary recall of specific lots of Special Kitty® wet, canned cat food due to health concerns potentially associated with ingredients believed to not meet the Company’s quality and safety standards.

Nassau Candy Distributors Issues Allergy Alert on Undeclared Milk Allergen in Nancy Adams, Dark Chocolate Graham Crackers
12/05/2019 Food Recall

Nassau Candy Distributors of Hicksville, NY is recalling two lots of 7.5 OZ (212g) Nancy Adams, Dark Chocolate Graham Crackers because they may contain undeclared milk allergens.

Dole Fresh Vegetables Announces Precautionary Limited Recall of Colorful Coleslaw
12/04/2019 Food Recall

Dole Fresh Vegetables, Inc. is voluntarily recalling a limited number of cases of Colorful Coleslaw.

Lin’s Waha Int’l Corp Issues Alert on Undeclared Sulfites and Cyclamates in “Suantianyangmei Waxberry and Bingtangyangmei Waxberry”
12/03/2019 Food Recall

Lin’s Waha Int’l Corp of Syosset, NY is recalling its 8.11 OZ (230G) packages of Suantianyangmei Waxberry and Bingtangyangmei Waxberry because they contain undeclared sulfites and cyclamates.

Fuji Food Products, Inc. Voluntarily Recalls Ready-to-Eat Sushi, Salads and Spring Rolls Manufactured on the East Coast Due to Potential Listeria monocytogenes Contamination
12/02/2019 Food Recall

Fuji Food Products, Inc. (Fuji) announced today the voluntary recall of ready to eat sushi, salads and spring rolls sold to select retailers and distributors along the East Coast and Upper Midwest.

UPDATE: Increased Rate of Mortality in Patients Receiving Abiomed Impella RP System - Letter to Health Care Providers
12/02/2019 Medical Recall

The FDA is providing the most recent, interim post-approval study results for Abiomed's Impella RP System.

UNFI Voluntarily Recalls Wild Harvest® Organic All-Purpose Flour, Unbleached
11/27/2019 Food Recall

UNFI announced today a voluntary national recall of five-pound bags of its Wild Harvest® Organic All-Purpose Flour, Unbleached

Hodgson Mill Issues Voluntary Recall of Unbleached All-Purpose White Wheat Flour Due to Potential Presence of Pathogenic E.coli
11/27/2019 Food Recall

Hodgson Mill of Effingham, IL, announced today a voluntary national recall of specific lots of its Unbleached All-Purpose White Wheat Flour (5 lb.)

B. Braun Medical Inc. Issues Voluntary Nationwide Recall of Twenty-Two (22) Lots of Blood Administration Sets, Due to Potential for Leakage at the Joint Between the Blood Filters and Tubing
11/26/2019 Medical Recall

B. Braun Medical Inc. [B. Braun] initiated a voluntary recall of twenty-two (22) lots of Blood Administration Sets. B. Braun identified through complaints and internal discrepancies the potential for leakage at the joint between the blood filters and tubing of these blood administration sets.

Northern Fisheries LTD. Voluntary Expanded Tuna Recall Press Release
11/25/2019 Food Recall

Northern Fisheries LTD of Little Compton, RI, has expanded their voluntary recall of frozen, wild-caught yellowfin Tuna Medallions (product of Vietnam) to include product sold directly to consumers. This recall is due to potentially elevated levels of histamine.

Allergy Alert Issued due to Undeclared Egg in Whole Foods Market Brand Raspberry Cheesecake Italian Gelato
11/23/2019 Food Recall

Whole Foods Market is voluntarily recalling one lot code of Whole Foods Market Raspberry Cheesecake Italian Gelato because these product units contain egg that is not listed on the product label. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening alle

“Euroline Foods LLC” Issues Alert on Undeclared Sulfites In “Dry Fruit Mix “Quince Compote” (Tainy Vostoka)”
11/21/2019 Food Recall

“Euroline Foods LLC” of Staten Island, NY is recalling its 17.65oz (500 gram) packages of “DRY FRUIT MIX “QUINCE COMPOTE” ” because they contain undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this

Mondelēz Global LLC Conducts Voluntary Recall of Limited Quantity of Cheese Nips (11 oz. Box) Product in the U.S. Due to Potential Presence of Foreign Material
11/20/2019 Food Recall

Mondelēz Global LLC announced today a voluntary recall of a limited quantity of Cheese Nips (11 oz. Box) product in the United States due to the potential presence of small food-grade yellow plastic pieces from a dough scraper that was incorporated into the production process of a small amount of pr

Update On Device Failure Associated with Getinge's Maquet/Datascope Intra-Aortic Balloon Pumps – Letter to Health Care Providers
11/19/2019 Medical Recall

The U.S. Food and Drug Administration (FDA) is providing an update on our evaluation of device failures associated with Getinge's Maquet/Datascope intra-aortic balloon pump (IABP) devices: Cardiosave (Hybrid and Rescue), CS300 and CS100/CS100i.

Device Failure Associated with Getinge's Maquet/Datascope Intra-Aortic Balloon Pumps - Letter to Health Care Providers
11/19/2019 Medical Recall

The FDA is evaluating recent reports of Getinge's Maquet/Datascope intra-aortic balloon pump (IABP) devices shutting down while running on battery power.

Precision Dose Inc. Issues Voluntary Nationwide Recall of Ranitidine Oral Solution, USP 150 mg/10 mL Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity.
11/19/2019 Medical Recall

Precision Dose Inc. is voluntarily recalling 5 lots of Ranitidine Oral Solution, USP 150 mg/10 mL to the consumer level. Ranitidine Oral Solution, USP 150 mg/10 mL, is being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

Select Varieties of Breakstone’s Cottage Cheese are Voluntarily Being Recalled Due to Potential Presence of Foreign Material
11/18/2019 Food Recall

Select varieties of Breakstone’s Cottage Cheese are voluntarily being recalled due to the potential presence of pieces of red plastic and metal that may have been introduced during production.

Go Raw, LLC Recalls One Lot of Quest Beef Because of Possible Salmonella Health Risk
11/18/2019 Food Recall

Go Raw, LLC, of Cottonwood Utah is recalling its 2lb. frozen bags of “Quest Beef Cat Food” because they may be contaminated with Salmonella.

Medtronic Recalls Remote Controllers for MiniMed Insulin Pumps for Potential Cybersecurity Risks
11/18/2019 Medical Recall

The remote controllers of some Medtronic MiniMed insulin pumps are vulnerable to cybersecurity risks. Unauthorized persons could record and replay the wireless communication from the remote to the MiniMed insulin pump leading to the administration of one ore more unintended boluses of insulin.

Philips Medical Systems (Cleveland) Recalls Forte Gamma Camera System Due to Potential for the Detector to Drop
11/18/2019 Medical Recall

The detector on the Forte Gamma Camera System has the potential to drop without warning which could result in a serious injury or death.

Zimmer Biomet Recalls ROSA Brain 3.0 Robotic Surgery System Due to Software Issue that Incorrectly Positions the Robotic Arm
11/18/2019 Medical Recall

Zimmer Biomet recalled the ROSA Brain Device due to a software issue which can drive the robotic arm to an incorrect position resulting in risks for the patient.

Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Ranitidine Hydrochloride 150mg and 300mg Capsules (Manufactured by Novitium Pharma LLC) Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)
11/15/2019 Medical Recall

Golden State Medical Supply, Incorporated (GSMS, Inc) based upon a manufacturer’s recall by Novitium Pharma LLC (Novitium), is voluntarily instituting a recall of all quantities and lots, within expiry, of Ranitidine HCl 150mg and 300mg Capsules to the consumer level because of potential presence of

CHS Inc. Recalls Payback® Feeds Because of Excess Magnesium Health Risk
11/14/2019 Food Recall

CHS Inc., based in Inver Grove Heights, Minnesota, is voluntarily recalling 67 tons of Payback® Feeds listed below due to potentially high levels of magnesium.

Natural Grocers Issues Recall on Organic Soybeans Due to Mold
11/14/2019 Food Recall

Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery chain, is recalling Natural Grocers brand 2-pound Organic Soybeans because they have the potential to contain mold. Consumers who may have purchased this product are advised to discontinue use and either throw it

Kettle Cuisine Issues Allergy Alert on Undeclared Fish and Wheat in Marketside Creamy Cauliflower Parmesan Soup 16oz
11/13/2019 Food Recall

Voluntarily recalling Marketside Brand Creamy Cauliflower Parmesan Soup 16oz because a limited quantity of retail pots may contain Fish and Wheat allergens not declared on the label.

Nature’s Rx Issues Voluntary Nationwide Recall of Silver Bullet 10 Male Enhancement Capsules due to an Undeclared PDE-5 Inhibitor Found in The Product
11/13/2019 Medical Recall

Nature’s Rx is voluntarily recalling lot: 01251ZX1, Expiry Date: 11/2022 of Silver Bullet (10 Male Enhancement Capsules). This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil, the active ingredient in Viagra, which is a PDE-5 inhibitor.

Taher Voluntarily Recalls Veggie & Ranch Cups With Cauliflower Because of Possible Health Risk
11/12/2019 Food Recall

Taher, Inc., in conjunction with Mann Packing Co., as part of a multi-state recall due to the potential risk of Listeria monocytogenes, in an abundance of caution is announcing a voluntary recall of vegetable cups served in select locations in Minnesota.

Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP, 150mg and 300mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity
11/12/2019 Medical Recall

Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey is voluntarily recalling Ranitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL to the consumer level. A listing of the recalled lots is identified below.
Ranitidine Tablets, USP, 150 mg and 300 mg

Russ Davis Wholesale Voluntarily Recalling Products Due to Possible Health Risk
11/09/2019 Food Recall

Russ Davis Wholesale (RDW), a leading fresh produce processor and distributor, in an abundance of caution is voluntarily recalling multiple products due to possible contamination of Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or

Mann Packing Co., Inc. Voluntarily Recalls Vegetable Products Sold in the United States and Canada Due to Potential Health Risks
11/08/2019 Food Recall

The voluntary recall is a response to a notification by the Food and Drug Administration and the Canadian Food Inspection Agency of a potential contamination with Listeria monocytogenes.

Mann Packing Recall of Vegetable Products Affects Whole Foods Market Stores; Grocer Issues Voluntary Recall of Multiple Products
11/08/2019 Food Recall

In response to Mann Packing Co., Inc’s recall of vegetable products, Whole Foods Market is voluntarily recalling multiple products from its stores in the United States. Mann Packing issued the recall because the vegetables may be contaminated with Listeria monocytogenes. No illnesses have been repor

Med Man Issues Voluntary Nationwide Recall of Up2 Due to Presence of Undeclared Sildenafil
11/08/2019 Medical Recall

Med Man Distribution is voluntarily recalling all lots of Up2 Dietary supplement There is no other all-natural libido for men and women to the consumer level.

American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups Due to the Detection of N-nitrosodimethylamine (NDMA) Impurity
11/08/2019 Medical Recall

American Health Packaging is voluntarily recalling eight lots of Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the f

Peekay International Inc., Issues Alert on Underclared Sulfites in “Swan Dry Yellow Dates” and “Keshav Dry Yellow Dates”
11/07/2019 Food Recall

Peekay International Inc. 56 12 56th Street, Maspeth, NY is recalling its 7 ounce and 14 ounce packages of “SWAN DRY YELLOW DATES” and “KESHAV DRY YELLOW DATES” food treats because they contained undeclared sulfites.

Mill Stream Corp. (Sullivan Harbor Farm) Issues a Voluntary Recall of Cold Smoked Salmon Because of Possible Health Risk
11/06/2019 Food Recall

Mill Stream Corp. (Sullivan Harbor Farm) of Hancock, Maine is voluntarily recalling ten lots of Cold Smoked Salmon because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product

Abbott Recalls CentriMag Circulatory Support System Motor Due to Pump and Motor Issues
11/06/2019 Medical Recall

Abbott is recalling their CentriMag System due to a calibration system error resulting from electromagnetic interference (EMI) that may cause low or no flow from the device, the console screen to blank, and various inaccurate alarms.

Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 38 Lots of Ranitidine Tablets 150mg, Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL Due to the Detection of NDMA (Nitrosodimethylamine) I
11/06/2019 Medical Recall

Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 1 lot of Ranitidine Tablets 150mg to the retail level and 37 lots of Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL to the consumer level due to the detection of NDMA (Nitrosodimethylamine) Impurity in

UPDATE: The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication
11/05/2019 Medical Recall

The U.S. Food and Drug Administration (FDA) is updating our 2017 safety communication.

The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication
11/04/2019 Medical Recall

The FDA is alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected.

Fagron Inc. Issues Voluntary Nationwide Recall of LETS GEL KIT Convenience Packs Due to Potential Microbial Contamination of Non-Sterile Products
11/01/2019 Medical Recall

Voluntarily Recalling all unexpired lots of LETS GEL KIT Convenience Packs to the hospital, pharmacy and distributor level. The product has been found to potentially contain microbial contamination in the non-sterile Suturagel Methylcellulose base component of the LETS GEL KIT Convenience Packs.

Wawona Frozen Food Voluntarily Recalls Frozen Raspberries Due to Possible Health Risk
10/31/2019 Food Recall

Wawona Frozen Foods is voluntarily recalling packages of frozen raspberries and frozen berry mixes containing raspberries sold at Aldi Grocery Stores and frozen raspberries sold at Raley's Family of Fine Stores because they have the potential to be contaminated with Hepatitis A.

ICU Medical, Inc. Issues a Voluntary Nationwide Recall of Lactated Ringer's Injection, USP and 0.9% Sodium Chloride Injection, USP Due to Presence of Particulate Matter
10/30/2019 Medical Recall

ICU Medical, Inc. (Nasdaq: ICUI) is voluntarily recalling one single lot of Lactated Ringer's Injection, USP, and one single lot of 0.9% Sodium Chloride Injection, USP. The products are being recalled to the hospital level due to the presence of particulate matter.

Ethicon Recalls ECHELON FLEX™ ENDOPATH® Staplers for Failure to Completely Form Staples
10/29/2019 Medical Recall

Some ECHELON FLEX ENDOPATH staplers may contain an out of specification component, which may cause malformed staples, which may cause patient injury or death.

Golden Dragon Fortune Cookies Inc. Issues Allergy Alert on Undeclared Milk in Chinese Almond Cookies
10/29/2019 Food Recall

Golden Dragon Fortune Cookies Inc., of Chicago, Illinois is recalling Golden Dragon Inc. Chinese Almond Cookies, because it may contain undeclared Milk.

North Bay Produce Voluntarily Recalls Fresh Apples Because of Possible Health Risk
10/29/2019 Food Recall

North Bay Produce, Inc. of Traverse City, Michigan is voluntarily recalling 2,297 cases and 2 bulk bins of fresh apples due to the potential to be contaminated with Listeria monocytogenes.

Update on Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft Systems: FDA Safety Communication
10/28/2019 Medical Recall

The FDA is evaluating new information about the risk of blood continuing to leak into the aneurysm (Type III endoleak) with Endologix AFX.

Mylan Pharmaceuticals Initiates Voluntary Nationwide Recall of One Lot of Alprazolam Tablets, USP C-IV 0.5 mg, Due to the Potential of Foreign Substance
10/26/2019 Medical Recall

Mylan Pharmaceuticals Inc. is conducting a voluntary nationwide recall of one lot (see table below) of Alprazolam Tablets, USP C-IV 0.5 mg, to the consumer/user level. This lot is being recalled due to the potential presence of foreign substance

Novitium Pharma Issues Voluntary National Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)
10/25/2019 Medical Recall

Voluntarily recalling all quantities and lots, within expiry, of Ranitidine Hydrochloride Capsules in the US to the consumer level. Ranitidine Hydrochloride Capsules are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

Lannett Issues Voluntary Nationwide Recall of Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/ml due to an Elevated Level of the Unexpected Impurity, N-Nitrosodimethylamine (NDMA)
10/25/2019 Medical Recall

Lannett Company, Inc. today announced that it is voluntarily recalling all lots within expiry of Ranitidine Syrup

Peekay International Inc., Expands the Recall For Underclared Sulfites In “Swan Dried Apricot” And “Keshav Dry Apricot”
10/24/2019 Food Recall

Peekay International Inc. 56 12 56th Street, Maspeth, NY is recalling its 7 ounce and 14 ounce packages of “SWAN DRY APRICOT” and “KESHAV DRY APRICOT” food treats because they contained undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening

Shivam Distributors Recalls “Dry Dates ” Due to Undeclared Sulfites
10/23/2019 Food Recall

Shivam Distributors of Longwood, FL is recalling its 7 ounce and 14 ounce packages of PARIVAR brand Dry Dates with batch # 125/BIBT because they contain high sulfite content, a preservative which could cause adverse health consequences with symptoms such as itchiness, upset stomach, headache.

Dr. Reddy’s Confirms its Voluntary Nationwide Recall of All Ranitidine Products in the U.S. Market
10/23/2019 Medical Recall

Nationwide recall on October 1, 2019, (at the retail level for over-the-counter products and at the consumer level for prescription products) of all of its ranitidine medications sold in US due to confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA

Sanofi Provides Update on Precautionary Voluntary Recall of Zantac OTC in U.S.
10/23/2019 Medical Recall

As a precautionary measure, Sanofi on Friday, October 18, intiated a voluntary recall of all Zantac OTC (over-the-counter) in the United States. This includes Zantac 150®, Zantac 150® Cool Mint, and Zantac 75®.

Perrigo Company plc Issues Voluntary Worldwide Recall of Ranitidine Due to Possible Presence of Impurity, N-nitrosodimethylamine (NDMA) Impurity in the Product
10/23/2019 Medical Recall

As a precautionary measure, Perrigo Company plc announced today that it has initiated a voluntary, worldwide product recall to the retail customer level of ranitidine (all pack sizes). The recall is being taken due to possible presence of a nitrosamine impurity called N-nitrosodimethylamine (NDMA).

GL Holdings Issues Voluntary Worldwide Recall of Green Lumber Products Due to Presence of Undeclared Tadalafil
10/22/2019 Medical Recall

GL Holdings is voluntarily recalling six lots of Green Lumber 2-, 4-, and 10-capsule packages purchased on or before August 10, 2019 to the consumer level. FDA analysis has found one lot of Green Lumber distributed between June and August 2019 to be tainted with tadalafil.

Johnson & Johnson Consumer Inc. to Voluntarily Recall a Single Lot of Johnson’s Baby Powder in the United States
10/18/2019 Food Recall

Johnson & Johnson Consumer Inc. (JJCI) announced that it is initiating a voluntary recall in the United States of a single lot of its Johnson’s Baby Powder in response to a U.S. Food and Drug Administration (FDA) test indicating the presence of sub-trace levels of chrysotile asbestos contamination.

Peekay International Inc. Issues Alert on Undeclared Sulfites in “KESHAV Dry Apricot”
10/16/2019 Food Recall

Peekay International Inc. 56 12 56th Street, Maspeth, NY is recalling its 7 ounce and 14 ounce packages of “KESHAV Dry Apricot” food treats because they contained undeclared sulfites.

2019 Biologics Recalls
10/16/2019 Medical Recall

2019 Biologics Recalls







Date Notification
Brand Name
Product Description

Important Drug Information - Humate-P [Antihemophilic Factor/von Willebrand Factor Complex (Human)]
10/16/2019 Medical Recall

CSL Behring LLC is alerting customers to a misalignment in the printing of the data on the folding box of Humate-P that might lead to confusion of the user.

Mical Seafood Inc Recalls Tuna Products for Possible Scombroid Poisoning
10/15/2019 Food Recall

Voluntarily initiated a recall of frozen, wild-caught yellowfin tuna poke cubes, tuna loins, tuna ground meat and 6oz tuna steaks because of potentially elevated levels of histamine. Elevated levels of histamines can produce an allergic reaction called scombroid fish poisoning.

Mical Seafood Inc. Voluntarily Expands Tuna Recall for Possible Scombroid Poisoning
10/15/2019 Food Recall

Mical Seafood, Inc. of Cooper City, FL, has voluntarily initiated an expanded recall of frozen, wild-caught yellowfin Tuna Loins, Tuna Poke, Tuna Steaks, Tuna Ground Meat, and Tuna Saku (products of Vietnam) due to potentially elevated levels of histamine.

Samurai, Inc. Issues Allergy Alert On Undeclared Fish In Furikake Popcorn 5oz. Package
10/15/2019 Food Recall

Samurai, Inc. of Honolulu, Hawaii is conducting a voluntary recall on 16,660 packages of Furikake Popcorn, because it may contain undeclared Fish. People who have an allergy or severe sensitivity to fish run the risk of serious or life-threatening allergic reaction if they consume these products.

Viatrexx Bio Incorporated Issues Voluntary Nationwide Recall of Sterile Injectables due to a Lack of Sterility Assurance
10/15/2019 Medical Recall

Viatrexx Bio Incorporated, Newark, Delaware is voluntarily recalling 10 mL sterile injectable vials of products, listed in the table below with lot numbers, to the consumer level. The products were sold exclusively to practitioners for office use. The products were manufactured in a manner that cann

Update: Recall of Frozen Cookie Dough Products Due to Allergen Health Risk is Expanded to Include Additional Lot Codes
10/11/2019 Food Recall

California New Foods has expanded its voluntary recall of frozen cookie dough products due to a lack of labeling that addresses the potential for the products to contain peanut and walnut allergens.

Fisherman’s Pride Processors Issues Recall of Shrimp Product Due to Misbranding and Undeclared Milk and Soy Allergens
10/10/2019 Food Recall

Fisherman’s Pride Processors Inc. of Vernon, CA is recalling 100 bags of Schwan’s Brand “Garlic Herb Shrimp” with date code 4A924608xx-B1 due to undeclared milk and soy.

UNFI Voluntarily Recalls Arla Apetina Marinated Feta & Olives in Oil, Pitted Because of Possible Health Risk
10/10/2019 Food Recall

The product requires refrigeration to ensure food safety and we have learned that some product distributed to retail customers from 2 UNFI distribution centers may have been exposed to temperatures above refrigeration during storage and/or distribution by UNFI’S customers.

Jumbo Foods Inc. Recalls Frozen & Fresh Chicken Salad Sandwiches Because of Possible Health Risk
10/10/2019 Food Recall

Jumbo Foods Inc. of Mukilteo, WA has issued a voluntary recall of Tuscan Sun (TS) brand chicken salad sandwiches, because it has the potential to be contaminated with Listeria monocytogenes

Allergy Alert for Undeclared Milk & Egg In White Parkerhouse Rolls Issued by Four Whole Foods Market Stores in Midwest
10/10/2019 Food Recall

Four Whole Foods Market stores in the Midwest region are voluntarily recalling White Parkerhouse Rolls because they may contain undeclared milk and egg.

Innoveix Pharmaceuticals, Inc. Issues Voluntary Recall of all Sterile Compounded Drug Products Due to a Lack of Sterility Assurance
10/10/2019 Medical Recall

Innoveix Pharmaceuticals, Inc. is voluntarily recalling all sterile compounded drug products, within expiry, to the consumer level. The products are being recalled due to a lack of assurance of sterility. These concerns arose following a routine inspection of the pharmacy by FDA.

Blue Bell Ice Cream Recalls a Select Lot of Butter Crunch Half Gallons for Possible Foreign Object
10/09/2019 Food Recall

Blue Bell Ice Cream is voluntarily recalling a select lot of half gallon Butter Crunch Ice Cream produced on a specific line on August 26, 2019 in its Sylacauga, AL plant because of the possibility the products may contain a foreign object.

Lipari Foods Issues Recall of Bulk Chicken Salads and Chicken Salad Sandwiches Due to Potential Contamination of Listeria Monocytogenes
10/08/2019 Food Recall

Voluntary recall of Lipari Old Tyme Bulk Chicken Salad, Lipari Old Tyme Bulk Cranberry Almond Chicken Salad, Premo Chicken Salad Wedge Sandwiches, Fresh Grab Chicken Salad Wedge Sandwiches, and Premo Signature Cranberry Almond Chicken Salad on Croissant due to Listeria monocytogenes

Lipari Foods Issues Recall of Ham & Cheese Wedge Sandwiches Due to Potential Contamination of Listeria Monocytogenes
10/08/2019 Food Recall

Lipari Foods has issued a voluntary recall of Premo Ham & Cheese Wedge Sandwiches and Fresh Grab Ham & Cheese Wedge Sandwiches due to potential contamination of Listeria monocytogenes

2019 Medical Device Recalls
10/08/2019 Medical Recall

The list below contains recalls that were issued in 2019.

Medtronic Recalls 6 French Sherpa NX Active Guide Catheters Due to Separation and Fragmentation Issue
10/08/2019 Medical Recall

Medtronic is recalling the 6 French Sherpa NX Active Guide Catheter due to a risk of the outer material separating from the device resulting in detached fragments that could result in the underlying stainless-steel braid wires being exposed.

ICU Medical Issues a Voluntary Nationwide Recall of Certain Lots of Plum and Sapphire Microbore Infusion Sets with Inline Filters
10/08/2019 Medical Recall

ICU Medical, Inc. announced a voluntary recall on 29 July 2019 of certain lots of Plum and Sapphire Microbore Infusion Sets with inline filters due to the potential for small amounts of fluid leaking out of the air vents on the inline filters. To date, ICU Medical is not aware of adverse events rela

ADM Animal Nutrition Recalls MoorMan’s® ShowTec® Lamb Creep DC
10/04/2019 Food Recall

ADM Animal Nutrition, a division of Archer Daniels Midland Company (NYSE: ADM), is voluntarily recalling 50-pound bags of MoorMan’s® ShowTec® Lamb Creep DC, product number 11153AE, because the product may contain high levels of copper.

The J. M. Smucker Company Issues Voluntary Recall of Specific Lots of Robin Hood® All Purpose Flour Distributed and Sold in the U.S. Only
10/04/2019 Food Recall

Out of an abundance of caution, The J. M. Smucker Company today announced a voluntary recall of specific lots of Robin Hood® All Purpose Flour distributed and sold in the U.S. due to possible E. coli contamination. This recall does not impact any Robin Hood® items sold in Canada.

Lung Injury Update: FDA Warns Public to Stop Using Tetrahydrocannabinol (THC)-Containing Vaping Products and Any Vaping Products Obtained Off the Street
10/04/2019 Medical Recall

FDA is strengthening its warning to consumers to stop using vaping products containing THC amid more than 1,000 reports of lung injuries—including some resulting in deaths—following the use of vaping products.

Coborn’s, Inc. Issues Recall of Select Chicken Salad Products Due to Possible Listeria Contamination
10/04/2019 Food Recall

Coborn's, Inc. is recalling select chicken salad products, which may have been contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

CBER FY 2018 Recall Postings
10/02/2019 Medical Recall

List of CBER FY 2018 Recall Postings.

CBER FY 2019 Recall Postings
10/02/2019 Medical Recall

Listing of CBER FY 2019 Recall Postings

2019 Safety Communications
10/01/2019 Medical Recall

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.

URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Devices: FDA Safety Communication
10/01/2019 Medical Recall

URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Devices: FDA Safety Communication

Dorset Cheese Voluntarily Recalled by North Atlantic and Northeast Whole Foods Market Stores Due to Possible Health Risk
09/30/2019 Food Recall

In response to a recall from Consider Bardwell Farm, Whole Foods Market stores in the Northeast and North Atlantic regions are voluntarily recalling Dorset cheese because of a potential contamination of Listeria monocytogenes

Cellect Products Inc. and Oglethorpe Ltd. Issue Voluntary Worldwide Recall of Cellect Unflavored Powder & Essentials Factor Cell Synergy Unflavored Powder, Lot #041907 Due to Potential Unsafe Levels of Arsenic and Lead
09/30/2019 Food Recall

The Cellect Unflavored Powder & Essentials Factor Cell Synergy Unflavored Powder has been found to have unsafe levels of Arsenic and Lead.

Consider Bardwell Farm Recalls Dorset, Slyboro, and Experience Because of Possible Health Risk
09/30/2019 Food Recall

These products may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems. Healthy individuals may suffer only short-term symptoms such as high fever, severe he

Mavidon Issues Voluntary Worldwide Recall of LemonPrep® Tubes and Single use cups
09/30/2019 Food Recall

Mavidon is voluntarily recalling 21 lots of LemonPrep® 4 ounce tubes and single use cups to user level. These products have been found to be contaminated with Burkholderia cepacia. The specific lots are listed below:

Rong Shing Trading Ny Inc. Issues Allergy Alert on Undeclared Milk in Ganchi Naiweitangpian Candies
09/27/2019 Food Recall

RONG SHING NY Trading Inc. of Brooklyn, NY, is recalling its 280-gram (9.8-ounce) packages of GANCHI NAIWEITANGPIAN candy because they may contain undeclared milk allergen. Consumers who are allergic to milk may run the risk of serious or life-threatening allergic reactions if they consume this prod

Keurig Dr Pepper Announces Voluntary Withdrawal of Unflavored Peñafiel Mineral Spring Water that Does Not Meet FDA Bottled Water Quality Standards
09/26/2019 Food Recall

Keurig Dr Pepper today announced it will voluntarily withdraw Peñafiel unflavored mineral spring water products, imported from Mexico, due to the presence of violative levels of arsenic.

Apotex Corp. Issues Voluntary Nationwide Recall of Ranitidine Tablets 75mg and 150mg (All pack sizes and Formats) due to the potential for Detection of an Amount of Unexpected Impurity,N-nitrosodimethylamine (NDMA) Impurity in the product
09/25/2019 Food Recall

Apotex Corp. is voluntarily, on a precautionary basis, recalling Ranitidine Tablets 75mg and 150mg (All pack sizes and Formats) to the Retail level. Apotex has learned from the U.S. Food and Drug Administration and other Global regulators that some ranitidine medicines including brand and generic fo

Weaver Fundraising, Llc Issues Allergy Alert on Undeclared Almonds, Cashews, and Pecans in Trail’s End Chocolatey Caramel Crunch Sold in Houston and Corpus Christi, Texas
09/25/2019 Food Recall

Weaver Fundraising, LLC (Indianapolis, IN) is voluntarily recalling 15 oz. tins containing Trail’s End Chocolatey Caramel Crunch because they may inadvertently contain almonds, cashews and pecans.

B. Braun Medical Inc. Issues Voluntary Nationwide Recall of one lot of one catalog item number of an Infusomat® Space Volumetric Infusion Pump Administration Set, Due to Potential Leakage
09/24/2019 Food Recall

B. Braun Medical Inc. [B. Braun] initiated a voluntary recall of one lot of Infusomat® Space Volumetric Infusion Pump Administration Sets (Catalog Number 363032, Lot Number 0061641410). The recalled administration sets are used to deliver parenteral fluids. B. Braun identified through customer compl

Euphoria Fancy Food Inc. Recalls “Capitan K Salmon Fillet” Due to Possible Health Risk
09/24/2019 Food Recall

Euphoria Fancy Food Inc of Brooklyn, NY is recalling its 7.05 oz packages of “CAPITAN K” salmon slightly salted pieces because they may be contaminated with Listeria monocytogenes.

Sandoz Inc. Issues Voluntary Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to An Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA), in the Product
09/24/2019 Food Recall

– Sandoz Inc. is voluntarily recalling all quantities and lots within expiry of Ranitidine Hydrochloride Capsules in the US to the consumer level because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA in batches of Sandoz Ranitidine Hydrochloride C

TDBBS Voluntarily Recalls Pig Ear Pet Treats No Illnesses Reported; Strictly Precautionary
09/24/2019 Food Recall

“This recall has been initiated due to possible Salmonella contamination, which poses a health risk. It is important to know that no illnesses have been reported, and the amount of affected product is minimal.

Frozen and Refrigerated Cookie Dough Products Recalled Due to Potential Health Risk from Allergens
09/24/2019 Food Recall

California New Foods has issued a voluntary recall of frozen and refrigerated cookie dough products due to a lack of labeling that addresses the potential for the products to contain peanut and walnut allergens.

Gramco, Inc. Recalls Hog Grower Pellets because of Elevated Vomitoxin Levels
09/23/2019 Food Recall

Gramco, Inc. of Springville, New York is recalling bags of Hog Grower Pellets because it contains levels of vomitoxin (a mycotoxin) that could be harmful to swine growth and potentially fatal to young swine.

Frozen and Refrigerated Cookie Dough Products Recalled Due to
09/23/2019 Food Recall

California New Foods has issued a voluntary recall of frozen and refrigerated cookie dough products due to a lack of labeling that addresses the potential for the products to contain peanut and walnut allergens.
People who have an allergy or severe sensitivity specific to peanuts and tree nuts run

Roland Foods, LLC Initiates a Voluntary Recall of Roland Red Lumpfish Caviar and Roland Black Lumpfish Caviar Due to Possible Health Risk
09/21/2019 Food Recall

Roland Foods, LLC of New York, New York is initiating a voluntary recall of its red and black lumpfish caviar products, which were manufactured at Ora ehf in Iceland, because they have the potential to be contaminated with Clostridium botulinum.

Ridley Block Operations Voluntarily Recalls a Batch of Ultralyx 2416-5 No Other Products are Affected; Distribution was Limited to Georgia and Florida
09/20/2019 Food Recall

Ridley Block Operations is voluntarily recalling one batch of Ultralyx 24-165. The product has been found to be out of specification, with elevated levels of non-protein nitrogen (NPN). The affected product could have adverse health effects on cattle.

Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium / Hydrochlorothiazide Tablets, USP
09/20/2019 Food Recall

Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity.

Abbott Laboratories Recalls Calcilo XD® Infant Formula
09/18/2019 Food Recall

Out of an abundance of caution, Abbott has voluntarily recalled a single lot of Calcilo XD® powder cans (13.2oz / 375g) with lot number 79696K80 in the United States and Canada due to an inconsistency in aroma and color in a small number of cans from this specific batch.

Southeastern Grocers Issues Voluntary Recall Variety pack cookie products sold in Southeastern Grocers stores
09/18/2019 Food Recall

Southeastern Grocers (SEG), the parent company of BI-LO, Fresco y Más, Harveys Supermarkets and Winn-Dixie stores, is issuing a voluntary recall for two 18-count cookie products sold in the bakery. The recall is due to the inclusion of an undeclared allergen in the products.

SCHWARTZ BROTHERS BAKERY ISSUES ALLERGY ALERT ON UNDECLARED EGG IN LEMON DESSERT BARS
09/18/2019 Food Recall

Schwartz Brothers Bakery of Seattle, WA is recalling 24 units of Lemon Dessert Bars, sell by date 09/21/19, because it may contain undeclared Egg. People who have an allergy or severe sensitivity to Egg run the risk of serious or life-threatening allergic reaction if they consume these products.

Teleflex Medical Recalls the Hudson RCI Sheridan and Sheridan Endotracheal Tubes Due to Risk of the Sheridan Connector Disconnecting from the Breathing Circuit
09/17/2019 Medical Recall

FDA has classified the voluntary action as a Class I recall for the Teleflex Medical Recalls the Hudson RCI Sheridan and Sheridan Endotracheal Tubes Due to Risk of the Sheridan Connector Disconnecting from the Breathing Circuit

Fitoterapia USA Inc. Issues Voluntary Nationwide Recall of MERO MACHO ARTIFICIAL PASSION FRUIT FLAVORED VITAMIN C LIQUID SUPPLEMENT Due to Presence of Active Ingredient Tadalafil
09/16/2019 Food Recall

Fitoterapia USA Inc., is voluntarily recalling 19,000 bottles of MACHO ARTIFICIAL PASSION FRUIT FLAVORED VITAMIN C LIQUID SUPPLEMENT, liquid dietary supplement to the consumer level. FDA analysis has found the product to be tainted with Tadalafil. Tadalafil is an active ingredient in a FDA- approved

General Mills Recalls Five Pound Bags of Gold Medal Unbleached All Purpose Flour
09/16/2019 Food Recall

General Mills announced today a voluntary national recall of five-pound bags of its Gold Medal Unbleached All Purpose Flour with a better if used by date of September 6, 2020.

Takeda Issues US Recall of NATPARA® (parathyroid hormone) for Injection Due to the Potential for Rubber Particulate
09/16/2019 Food Recall

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the company is issuing a US recall for all doses of NATPARA® (parathyroid hormone) for Injection (25 mcg, 50 mcg, 75 mcg, and 100 mcg). This recall is being conducted after discussions with the FDA and is effec

Darmerica LLC Issues Voluntary Nationwide Recall of Quinacrine Dihydrochloride Due to A Labeling Error
09/14/2019 Food Recall

Darmerica LLC is voluntarily recalling two lots, DR4654A and DL4654A, of Quinacrine Dihydrochloride, bulk API powder packaged in Amber HDPE Bottles to the consumer level. This product is being recalled due to a label mix-up. Product intended for further compounding use by pharmacies labeled as Quin

Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib): Drug Safety Communication - Due to Rare but Severe Lung Inflammation
09/13/2019 Medical Recall

FDA is warning that Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib) used to treat some patients with advanced breast cancers may cause rare but severe inflammation of the lungs.

Zantac (ranitidine): Safety Information - NDMA Found in Samples of Some Ranitidine Medicines
09/13/2019 Medical Recall

FDA has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain NDMA.

KRS Global Biotechnology, Inc. Issues Voluntary Nationwide Recall of All Human and Animal Sterile Drug Products Due to Lack of Assurance of Sterility
09/13/2019 Food Recall

KRS Global Biotechnology, Inc. is voluntarily recalling all lots of unexpired human and animal drugs intended to be sterile to the consumer level. The products are being recalled due to lack of assurance of sterility.

KRS Global Biotechnology, Inc. Issues Voluntary Nationwide Recall of All Human and Animal Sterile Drug Products Due to Lack of Assurance of Sterility
09/13/2019 Food Recall

KRS Global Biotechnology, Inc. is voluntarily recalling all lots of unexpired human and animal drugs intended to be sterile to the consumer level. The products are being recalled due to lack of assurance of sterility.

Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib): Drug Safety Communication - Due to Rare but Severe Lung Inflammation
09/13/2019 Medical Recall

FDA is warning that Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib) used to treat some patients with advanced breast cancers may cause rare but severe inflammation of the lungs.

Urban Remedy Voluntarily Recalls 76 Salads, Wraps That May Contain E.Coli Bacteria No Illnesses Reported, Company Taking Preventive Action
09/13/2019 Food Recall

Urban Remedy, a California-based producer and retailer of ultra-fresh, organic meals, is voluntarily recalling 76 salads and wraps that contain spinach that may be contaminated with E. coli. Seventy-six salads and wraps are still unaccounted for. No juices or any other products are being recalled.

Rong Shing Issues Allergy Alert on Undeclared Eggs and Milk in FuPaiYuan Nougat Candies
09/12/2019 Food Recall

RONG SHING of Brooklyn, NY is recalling its 450g packages of FuPaiYuan Nougat candy because they may contain undeclared eggs and milk allergens

Rong Shing Issues Allergy Alert on Undeclared Eggs and Milk in FuPaiYuan Matcha Candies
09/12/2019 Food Recall

RONG SHING of Brooklyn, NY is recalling its 450g packages of FuPaiYuan Matcha candy because they may contain undeclared eggs and milk allergens

Zantac (ranitidine): Safety Information - NDMA Found in Samples of Some Ranitidine Medicines
09/12/2019 Medical Recall

FDA has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain NDMA.

Stark Group International Issues Allergy Alert on Undeclared Milk Allergens in Ritter Sport KAFFEESPLITTER - 3.5 Ounce /100 Gram
09/12/2019 Food Recall

Stark Group International of Greenvale, NY is recalling all codes of its 100 gram packages of Ritter Sport -KAFFEESPLITTER because they may contain undeclared milk allergens.

House Of Spices (India) Issues Recall of "MDH Sambar Masala" Due To Salmonella Contamination
09/11/2019 Food Recall

House of Spices (India) is recalling different lots of “MDH SAMBAR MASALA”, 3.5oz (100g) UPC code 6291103750327.This product is produced by R-PURE AGRO SPECIALITIES and distributed by HOUSE OF SPICES (INDIA). This product was tested by FDA through a certified laboratory to be positive for Salmonella

Recall of Yellowfin Tuna Steaks Issued
09/11/2019 Food Recall

On September 6, 2019, Alfa International Seafood, Inc. of Medley, FL, voluntarily initiated a recall of refrigerated, wild-caught yellowfin tuna loins because of potentially elevated levels of histamine.

Hospira, Inc., Issues A Voluntary Nationwide Recall for one lot of BACTERIOSTATIC WATER for Injection, USP, due to a Potential Lack of Sterility Assurance
09/11/2019 Food Recall

Hospira, Inc., a Pfizer company, is voluntarily recalling BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial, lot W20308, to the Hospital/Retail level. Hospira initiated this recall due to lack of confirmation of sterilization for some vials from this lot.

Hy-Vee Voluntarily Recalls Several Hy-Vee Mealtime Asian Entrees Due to Undeclared Milk Allergen
09/11/2019 Food Recall

Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling seven of its Hy-Vee Mealtime Asian Entrees after discovering the liquid egg used to make the fried rice contains milk, which is not declared on the product label.

Tetrahydrocannabinol (THC)-containing Vaping Products: Vaping Illnesses
09/09/2019 Medical Recall

Consumers are likely aware of the recent reports of respiratory illnesses – including some resulting in deaths – following the use of vaping products.The FDA is working closely with the CDC, as well as state and local public health partners to investigate them as quickly as possible.

test article-5/9-FT-Medwatch RSS Feed
09/05/2019 Medical Recall

test article-5/9-FT-Medwatch RSS Feed

E-Cigarette Products: Safety Communication - Due to the Incidents of Severe Respiratory Disease Associated with Use of an E-Cigarette Product
08/30/2019 Medical Recall

Both the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention are working tirelessly to investigate the distressing incidents of severe respiratory disease associated with use of e-cigarette products.

Hepatitis C Medicines (Mavyret, Zepatier, and Vosevi): Drug Safety Communication - Due to Rare Occurrence of Serious Liver Injury in Some patients with Advanced Liver Disease
08/29/2019 Medical Recall

FDA has received reports that the use of Mavyret, Zepatier, or Vosevi to treat chronic Hepatitis C in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure.

Xeljanz, Xeljanz XR (tofacitinib): Drug Safety Communication - Due to an Increased Risk of Blood Clots and Death with Higher Dose
07/26/2019 Medical Recall

Drug Safety Communication - Due to an Increased Risk of Blood Clots and Death with Higher Dose

Fecal Microbiota for Transplantation: Safety Communication- Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms
06/19/2019 Medical Recall

FDA MedWatch Alert regarding Fecal Microbiota for Transplantation: Safety Communication- Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms

E-cigarette: Safety Communication - Related to Seizures Reported Following E-cigarette Use, Particularly in Youth and Young Adults
05/16/2019 Medical Recall

Safety Communication - Related to Seizures Reported Following E-cigarette Use, Particularly in Youth and Young Adults

Teva Pharmaceuticals USA, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium 25 mg and 100 mg Tablets USP, Sold Exclusively to Golden State Medical Supply
04/26/2019 Food Recall

Teva Pharmaceuticals USA, Inc. has initiated a voluntary recall in the United States, to the patient level, of 35 lots of bulk Losartan Potassium USP Tablets (6 lots of 25 mg strength and 29 lots of 100 mg strength).

Legacy Pharmaceutical Packaging, LLC Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity Found in the Active Pharmaceutical Ingredien
04/25/2019 Food Recall

Legacy Pharmaceutical Packaging, LLC is expanding its consumer-level recall of 3 repackaged lots Losartan Tablets USP 50mg to include one additional lot.

Jurox Incorporated is Voluntarily Recalling Two Lots of Alfaxan Unpreserved, an Intravenous Injectable Anaesthetic
04/24/2019 Food Recall

This recall has been initiated due to an out of specification result for clarity observed in the stability program. The presence of the aluminum phosphate precipitate presents a potential risk that intravascular (I.V.) injection of product containing this precipitate could result in blood vessel in

Alvogen Inc. Issues Voluntary Nationwide Recall of Fentanyl Transdermal System Due to Product Mislabeling
04/21/2019 Food Recall

Alvogen, Inc. is voluntarily recalling two lots of Fentanyl Transdermal System 12 mcg/h transdermal patches to the consumer level.

Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP
04/18/2019 Food Recall

Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The Recall is expanded to include an additional 36 lots of Losartan potassium Tablets USP and 68 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP

Weis Markets Issues Recall for Undeclared Egg Allergen In WQ Banana Puddin Ice Cream
04/17/2019 Food Recall

Weis Markets today said it has issued a recall for its Weis Quality Banana Puddin Ice Cream (48oz) since the product’s ingredient label fails to list an egg allergen due to a supplier error. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products. There have been no reports of illness from customer’s consuming this product to date.

Mondelēz Global LLC Conducts Voluntary Recall of Certain Chewy Chips Ahoy 13oz Due to Unexpected Solidified Ingredient in Product in the US
04/17/2019 Food Recall

Mondelēz Global LLC announced today a limited voluntary recall in the United States of certain Chewy Chips Ahoy 13oz cookies. This voluntary recall is being conducted because of the potential for certain product to contain an unexpected solidified ingredient. Some reports of potential adverse health effects have been received.

Jensen Tuna of Louisiana is Voluntarily Recalling Frozen Ground Tuna Imported from JK Fish, Because it may Potentially be Contaminated with Salmonella
04/16/2019 Food Recall

Jensen Tuna of Louisiana is Voluntarily Recalling Frozen Ground Tuna Imported from JK Fish, Because it may Potentially be Contaminated with Salmonella. The frozen product, individually packaged in clear plastic one-pound bags, is sold in white wax 20 lb. boxes. The product is only sold as a wholesale case with twenty bags in each case. The lot numbers are z266, z271 and z272.

Hercules Candy LLC Issues Allergy Alert on Undeclared Peanuts in Cashew Brittle Bits
04/16/2019 Food Recall

Hercules Candy LLC . of East Syracuse, NY, is recalling its 4 ounce packages of Cashew Brittle Bits because they may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product. The recalled Cashew Brittle Bits were distributed from the brick and mortar retail in East Syracuse and nationally through the website www.herculescandy.com.

Unilever Issues Allergy Alert on Undeclared Tree Nut in Limited Quantities of Ben & Jerry’s Coconut Seven Layer Bar Bulk and Chunky Monkey Pint
04/16/2019 Food Recall

Unilever is voluntarily recalling a limited quantity of Ben & Jerry’s Coconut Seven Layer Bar bulk and Ben & Jerry’s Chunky Monkey pints, which may inadvertently contain tree nuts including almonds, Brazil nuts, and hazelnuts that are not declared in the ingredient list or allergy information list. Both affected products include a “Contains Walnuts” and a “May contain other tree nuts” label on the back of the pack. Persons who have an allergy or severe sensitivity to these undeclared tree nuts run the risk of a serious or life-threatening allergic reaction if they consume the recalled products.

Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Product Because of Possible Health Risk
04/13/2019 Food Recall

Caito Foods is voluntarily recalling fresh cut watermelon, fresh cut honeydew melon, fresh cut cantaloupe and fresh cut mixed fruit containing one of these melons, produced at the Caito Foods facility in Indianapolis because these products have the potential to be contaminated with Salmonella Carrau, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

SD Import Issues Voluntary Nationwide Recall of Aphrodisiac Capsules Due to Presence of Undeclared Sildenafil
04/11/2019 Food Recall

SD Import, LLC is voluntarily recalling all lots of Aphrodisiac, Capsules to the consumer level. The products have been found to be tainted with sildenafil. FDA analysis has found the product to be tainted with sildenafil. Sildenafil is an active pharmaceutical ingredient in FDA approved product used in the treatment of erectile dysfunction. The presence of sildenafil in Aphrodisiac capsules renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

Great American Marketing Company Recalls Ready To Eat Products Because of Possible Health Risk
04/10/2019 Food Recall

Great American Marketing Company of Houston, Texas is recalling Ready to Eat Sandwiches, Wraps and Salads because they have the potential to be contaminated with LISTERIA MONOCYTOGENES , an organism which can cause serious and sometimes fatal infections in young children, frail and elderly people and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria Infection can cause miscarriages and still births among pregnant women.

Brian Richardson DBA “In Tha Pink” Issues Voluntary Nationwide Recall of Kopi Jantan Tradisional Natural Herbs Coffee Due to Presence of Undeclared Sildenafil and Tadalafil
04/08/2019 Food Recall

Brian Richardson DBA “In Tha Pink”, is voluntarily recalling lots with the expiration of October 13, 2020 (13/10/2020) of ground Kopi Jantan Tradisional Natural Herbs Coffee to the consumer level. FDA analysis has found the product to be tainted with Sildenafil and Tadalafil

Thorgensen Family Farm Recalls Raw Frozen Ground Pet Food (Rabbit; Duck; Llama; Pork) Because of Possible Listeria Monocytogenes Health Risk
04/07/2019 Food Recall

Thogersen Family Farm of Stanwood, WA is voluntarily recalling raw frozen ground pet food because it has the potential to be contaminated with Listeria monocytogenes. The following varieties, packaged in two pound packs, are included in this recall: course ground rabbit, course ground mallard duck, ground llama, and ground pork frozen raw pet food

Conagra Brands Announces Recall of a Limited Amount of Hunt’s Tomato Paste Cans Due to Potential Presence of Mold
04/04/2019 Food Recall

Conagra Brands, Inc. (NYSE: CAG) is voluntarily recalling a limited amount of Hunt’s Tomato Paste No Salt Added six ounce cans. After the canning process, the final product could have been damaged, creating the potential for mold. Conagra Brands became aware of the issue after receiving calls from consumers.

E-cigarette: Safety Communication - Related to Seizures Reported Following E-cigarette Use, Particularly in Youth and Young Adults
04/03/2019 Medical Recall

The FDA has become aware that some people who use e-cigarettes have experienced seizures, with most reports involving youth or young adult users.

Wakefern Food Corp. Voluntarily Recalls Wholesome Pantry Organic Nut Butters Because of Possible Health Risk
04/02/2019 Food Recall

Wakefern Food Corp. has initiated a voluntary recall of a variety of Wholesome Pantry Organic nut butters because they may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. No illnesses related to the recall have been reported.

NadaMoo! Voluntarily Recalls Select Pints of Strawberry Cheesecake Due to Undeclared Almond
04/01/2019 Food Recall

Little Red Rooster Ice Cream Company, d/b/a NadaMoo! (“NadaMoo!”) announced a limited voluntary recall of approximately 26,000 pints of its Strawberry Cheesecake Non-Dairy Frozen Dessert because they contain an undeclared almond ingredient. People who have an allergy or severe sensitivity to almonds run the risk of a serious or life-threatening allergic reaction if they consume the recalled products.

Nestle Purina PetCare Company Voluntarily Recalls a Limited Amount of Muse Wet Cat Food Natural Chicken Recipe in Gravy in Three-ounce Cans due to the Potential Presence of Rubber Pieces
03/30/2019 Food Recall

Out of an abundance of caution, Nestle Purina PetCare Company is voluntarily recalling a limited amount of Muse wet cat food Natural Chicken Recipe in Gravy in three-ounce cans. The product could contain rubber pieces that are translucent yellow with a blue backing, which may present a potential choking hazard.

Thomas Hammer Coffee Roasters Inc. Issues Allergy Alert on Undeclared Egg in Blueberry Bread
03/29/2019 Food Recall

Thomas Hammer Coffee Roasters Inc. of Spokane, WA is recalling 15 loaves of Blueberry Bread because it may contain undeclared EGG. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume this product.

Theo Chocolate Issues Allergy Alert on Undeclared Milk in 3oz Sea Salt 70% Dark Chocolate Bars
03/28/2019 Food Recall

Theo Chocolate of Seattle, WA is voluntarily recalling 3oz Sea Salt 70% Dark Chocolate bars (UPC 8 74492 00325 8) because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume this product.

USA LESS Issues Voluntary Nationwide Recall of LEOPARD Miracle Honey Due to Presence of Undeclared Sildenafil
03/25/2019 Food Recall

USA LESS, is voluntarily recalling all lots of LEOPARD Miracle Honey, to the consumer level. FDA analysis has found LEOPARD Miracle Honey to be tainted with sildenafil.

Henry Avocado Recalls Whole Avocados Because Of Possible Health Risk
03/24/2019 Food Recall

Henry Avocado Corporation is voluntarily recalling California-grown whole avocados sold in bulk at retail stores because they have the potential to be contaminated with Listeria monocytogenes. Henry Avocado is issuing this voluntary recall out of an abundance of caution due to positive test results on environmental samples taken during a routine government inspection at its California packing facility. There are no reported illnesses associated with this recall.

Ata Int. Inc. Issues Voluntary Nationwide Recall of BLUEFUSION Capsules, due to presence of Undeclared Sildenafil, Tadalafil, Desmethyl carbodenafil, Dithiodesmethyl carbodenafil, Scutellarin and Daidzein
03/21/2019 Food Recall

Ata Int. Inc. is voluntarily recalling all lots within expiry of BLUEFUSION Capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil, tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin and daidzein. Sildenafil and tadalafil are FDA approved drugs for the treatment of male erectile dysfunction and are in a class of drugs called phosphodiesterase (PDE-5) inhibitors. Desmethyl carbodenafil and dithiodesmethyl carbodenafil are analogues of PDE-5 inhibitors and are likely to have the same pharmacological activity as PDE-5 inhibitors and thus carry the same clinical risks. Scutellarin and daidzein are derived from plants or herbs.

Hill’s Pet Nutrition Expands Voluntary Recall of Select Canned Dog Food for Elevated Vitamin D
03/21/2019 Food Recall

Hill’s Pet Nutrition today announced it is expanding its recall of select canned dog food products due to elevated levels of vitamin D.

Better Made Snack Foods Issues Allergy Alert on Undeclared Milk In 10 Ounce $3.99 Original Potato Chips
03/21/2019 Food Recall

The recall was initiated after it was discovered that a package of 10-ounce Original Potato Chips dated 10 AUG 2019 did not contain Original Potato Chips but instead contained Cheddar and Sour Cream Potato Chips which contain milk. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes which may have affected 660 bags of 10-ounce Original Potato Chips.

Century Snacks LLC Recalls Snak Club Honey Bliss Nut Mix Due to Undeclared Allergen
03/21/2019 Food Recall

Century Snacks, LLC of Commerce, CA is recalling all packages of 3-oz. and 5.75-oz. SNAK CLUB HONEY BLISS NUT MIX due to undeclared MILK. People who have an allergy or severe sensitivity to MILK run the risk of serious or life-threatening allergic reaction if they consume these products.

Kingston Pharma, LLC RECALLS " DG™/health NATURALS baby Cough Syrup + Mucus” Because of Possible Health Risk
03/20/2019 Food Recall

Kingston Pharma, LLC of Massena, NY is recalling Lot KL180157 of its 2-fluid ounce (59 mL) bottles of DG™/health NATURALS baby Cough Syrup + Mucus” because it has the potential to be contaminated with Bacillus cereus/ Bacillus circulans. Bacillus cereus in food products has the potential to produce two forms of gastrointestinal illness, one being a syndrome primarily of vomiting, and the other of diarrhea. Most often, illnesses are mild and self-limiting, although more serious and even lethal cases have occurred. Individuals at risk for more severe forms of illness include infants, young children, and others with weakened immune systems. No illnesses have been reported to date in connection with this problem with the use of DG™/health NATURALS baby Cough Syrup + Mucus.

Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter
03/18/2019 Food Recall

Mylan Institutional LLC is conducting a voluntary nationwide recall of two lots (see table below) of Levoleucovorin Injection, 250 mg/25 mL to the consumer/user level. The lots were manufactured by Alidac Pharmaceuticals Limited and distributed by Mylan Institutional LLC.

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient
03/16/2019 Food Recall

Legacy Pharmaceutical Packaging, LLC is recalling 3 repackaged lots of Losartan Tablets USP 50mg to the consumer level. This recall was prompted due to Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace
03/15/2019 Food Recall

Earth City, MO, Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level. This recall was prompted due to Camber Pharmaceuticals, Inc. issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

Hospira, Inc. Issues a Voluntary Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP Due to the Presence of Particulate Matter
03/15/2019 Food Recall

Hospira, Inc., a Pfizer company, is voluntarily recalling lot numbers 79-238-EV, 79-240-EV and 80-088-EV, NDC# 0409-6625-02, of 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL), to the Hospital/Institution level. The recall was initiated due to the presence of particulate matter, confirmed as glass.

Surtidoras Bakery Inc. Issues Allergy Alert on Undeclared Milk in Marble Muffin, Banana Muffin, and Blueberry Muffin
03/15/2019 Food Recall

Surtidoras Bakery Inc. of Auburn, Washington is recalling Marble Muffin, Banana Muffin, and Blueberry Muffin because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

Stokes Healthcare Inc. Issues Voluntary Nationwide Recall of Pilocarpine 0.1% Ophthalmic Solution Due to a High Level of Preservative
03/13/2019 Food Recall

Stokes Healthcare Inc. is voluntarily recalling 1 lot of 81 units of Pilocarpine 0.1% Ophthalmic Solution, to the consumer and veterinarian office levels. The ophthalmic solution has been found to contain a higher level of the preservative benzalkonium chloride than is typical.

Hometown Food Company Recalls Two Production LOT Codes of Pillsbury® Unbleached All-Purpose 5lb Flour Due to Possible Health Risk
03/13/2019 Food Recall

Please be advised the Hometown Food Company initiated a limited, voluntary retail-level recall on two specific lot codes of its Pillsbury® Unbleached All-Purpose 5 lb Flour (UPC 51500-22241) because it may be contaminated with Salmonella. Only Best If Used By Dates APR 19 2020 and APR 20 2020 are impacted.

Claire’s Stores, Inc., Announces Voluntary Recall of Three Make-Up Products
03/12/2019 Food Recall

Out of an abundance of caution, today Claire’s Stores, Inc., announced a voluntary recall of three cosmetic products: Claire’s Eye Shadows, Claire’s Compact Powder and Claire’s Contour Palette. We initiated this voluntary recall after testing by the U.S. Food and Drug Administration indicated the possible presence of asbestos fibers in product samples from one lot of each product. Inhalation of asbestos over time has been linked to serious adverse health consequences.

Fullei Fresh Recalls Organic Bean Sprouts Because of Possible Health Risk
03/08/2019 Food Recall

Fullei Fresh of Miami, Florida is voluntarily recalling Organic Bean Sprouts because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Norbrook Laboratories Limited Recalls Veterinary Products for Health Risk
03/07/2019 Food Recall

Norbrook Laboratories Limited of Newry, Northern Ireland is recalling two lots of Enroflox® 100 Injection (enrofloxacin), two lots of Noromectin® Injection (ivermectin) and two lots of Ivermax® 1% Injection (ivermectin) to the veterinarian/consumer level as a precautionary measure as product sterility cannot be assured. There is a concern that if the sterility of these products has been compromised, use of these products could result in introduction of infectious agents to the animal. This may result in the need for medical intervention(s) including, but not limited to the need for supportive care, antibiotics, and/or antifungal drugs.

American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity
03/07/2019 Food Recall

American Health Packaging is voluntarily recalling one lot of Valsartan Tablets, USP, 160 mg to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-Nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. This recall is being initiated in response to the recall by the manufacturer (Aurobindo Pharma USA, Inc.), which included the affected lot that was repackaged by American Health Packaging.

McDaniel Life-Line LLC Issues Voluntary Worldwide Recall of Life-Line Water
03/06/2019 Food Recall

McDaniel Life-Line LLC is voluntarily recalling all lots of Life-Line Water to the consumer level. This product is being recalled because FDA analysis found the product to be contaminated with Pseudomonas aeruginosa.

Apotex Corp. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, 28x3 Blister Pack/Carton Due to Possibility of Missing/Incorrect Tablet Arrangement
03/04/2019 Food Recall

Weston, Florida, Apotex Corp. is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP to the patient /user level. The four recalled lots of Drospirenone and Ethinyl Estradiol Tablets, USP may possibly contain defective blisters with incorrect tablet arrangements and/or an empty blister pocket. The affected product is manufactured by Oman Pharmaceutical Products Co. LLC. Oman under the subcontract from Helm AG, Nordkanalstrasse 28, Hamburg, 20097, Germany.

Sunstone Organics Issues Voluntary Nationwide Recall of Select Kratom Products Due to Potential Contamination by Salmonella
03/01/2019 Food Recall

Springfield, OR, Sunstone Organics is voluntarily recalling two lots of Sunstone Organics Kratom. These two lots include Sunstone Organics White Vein Kratom Lot 119 and Sunstone Organics Maeng Da Kratom Lot 124A in both capsules and powder form and in all sizes. The products have been found to potentially be contaminated with salmonella.

Updated: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium /Hydrochlorothiazide Tablets, USP
03/01/2019 Food Recall

Torrent Pharmaceuticals Limited is voluntarily recalling 60 lots of Losartan potassium tablets USP and 54 lots of Losartan potassium/ hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

Asia Foods Distributor Inc. Issues Allergy Alert on Undeclared Milk Allergens in “Nova Salted Biscuit”
03/01/2019 Food Recall

Asia foods Distributor Inc of 56-29 56 Drive, Maspeth, NY 11378 is recalling its 14.08 ounce packages of “Nova Salted Biscuit” food treats because they may contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or lifethreatening allergic reactions if they consume this product.

AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 38 Lots of Amlodipine Valsartan Tablets USP and Valsartan Tablets, USP due to the detection of NDEA (N-Nitrosodiethylamine) Impurity.
03/01/2019 Food Recall

AurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. This recall is an expansion of the recall initiated 12/31/18 The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. The expansion relates to lots distributed under the labels for AurobindoPharma USA, Inc. and Acetris Health, LLC. To date, AurobindoPharma USA, Inc. has not received any reports of adverse events related to this recall.

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical
03/01/2019 Food Recall

Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

Joy Gourmet Foods LLC Issues Allergy Alert on Undeclared Sulfites
02/27/2019 Food Recall

Joy Gourmet Foods Inc. of Maspeth, NY is recalling its Joy Brand Chutneys and Pastes products because they contain undeclared sulfites.. People who have allergies to sulfites run the risk of serious or life-threatening allergic reaction if they consume this product. The recalled Joy Brand Chutneys and Pastes were distributed in NY, NJ,and CT in retail stores.The products comes in 8 oz,14 oz,16 oz, and 26 oz, 32 oz. clear glass jar packages and marked on the labels as follows:

UTZ Quality Foods Issues Allergy Alert on Undeclared Milk in Bachman 10 Ounce Twist
02/26/2019 Food Recall

Utz Quality Foods, LLC., is voluntarily recalling a specific expiration date code of Bachman 10 oz Twist Pretzel packages due to undeclared milk. This recall was initiated after reviewing production records which identified a small number of packages were mislabeled.

ICU Medical Issues a Voluntary Nationwide Recall of Certain Lots of ChemoLock™ and ChemoClave® Vial Spikes Due to the Potential for Burr Particulate
02/26/2019 Food Recall

ICU Medical, Inc. today announced a voluntary recall of certain lots of ChemoLock™ and ChemoClave® Vial Spikes due to the potential for burr particulate originating from the protective cap used in the assembly of the device

Southern Specialties Voluntarily Recalls Bagged Green Beans and Butternut Squash Distributed in Southeast because of Possible Health Risk
02/25/2019 Food Recall

Southern Specialties Inc. of Pompano Beach, Florida is voluntarily recalling select bags of Marketside brand green beans and butternut squash because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

Golean Detox USA Issues Voluntary Nationwide Recall of Golean DETOX Capsules Due to Presence of Undeclared Sibutramine and Phenolphthalein
02/25/2019 Food Recall

Golean Detox USA, Charlotte, NC is voluntarily recalling all lots within expiry of Golean DETOX capsules to the consumer level. FDA analysis has found Golean DETOX capsules to be tainted with undeclared sibutramine and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market due to safety concerns. Phenolphthalein was once an ingredient used in over-the-counter laxatives, but because of concerns of carcinogenicity is not currently approved for marketing in the United States. The presence of sibutramine and phenolphthalein in Golean DETOX renders it an unapproved drug for which safety and efficacy has not been established and, therefore, subject to recall.

B&G Foods Voluntarily Recalls a Limited Number of Jars of Victoria® Marinara Sauce Due to Possible Undeclared Cashew
02/25/2019 Food Recall

B&G Foods announced today it is voluntarily recalling 1,280 cases of a single date code of 40 oz. Victoria Marinara Sauce, with a “best by” date of 03/06/2022, after learning that the product may contain cashew allergens that are not declared on the product’s ingredient statement. People who have an allergy or severe sensitivity to cashew run the risk of serious or life-threatening allergic reaction if they consume this product. There is no health risk associated with this product for individuals without an allergy to tree nuts.

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity
02/25/2019 Food Recall

Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited.

Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients
02/25/2019 Medical Recall

FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis

Meijer Recalls Mint Meijer Brand Ultimate Chocolate Mint Chip Cookies Due to an Undeclared Soy Allergen
02/22/2019 Food Recall

Meijer is announcing a voluntary recall of its Meijer brand Ultimate Chocolate Mint Chip Cookies because soy it is not properly declared on the label.

Jacques Torres Manufacturing LLC Issues Allergy Alert on Undeclared Milk Allergens in “Jacques” Big Daddy Dark Chocolate Bar
02/21/2019 Food Recall

Jacques Torres Manufacturing LLC of Brooklyn, New York is recalling its 2.2 lbs. (1kg), “Jacques” Big Daddy Dark Chocolate Bar, because it contains undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life-threatening allergic reaction if they consume this product.

Gilda Industries, Inc. Issues Allergy Alert on Undeclared Milk in Butter Pound Cake
02/20/2019 Food Recall

Gilda Industries, Inc voluntarily recalls select code dates and manufacturing lot numbers of Panque – Butter pound cake because they may contain undeclared milk . People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume the product contained inside the recalled panque –butter pound cake

Concord Fresh Success Recall Mild Salsa Seasoning Mix Due To Undeclared Milk Allergen
02/19/2019 Food Recall

Concord Foods, LLC of Brockton, Massachusetts is recalling Concord Fresh Success Mild Salsa Seasoning Mix because it may contain undeclared milk allergen. People who have an allergy or severe sensitivity to milk allergen run the risk of serious or lifethreatening allergic reaction if they consume this product.

Chukar Cherries Expands Recall Of Amaretto Rainier Ultra Dark Chocolate Cherries Pouches Due To Undeclared Milk
02/18/2019 Food Recall

February 18, 2019, Chukar Cherries of Prosser, WA is recalling 7.5oz Amaretto Rainier Ultra Dark Chocolate Cherries because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

Smoked Alaska Seafoods, Inc. Recalls 6.5 oz Jars & Cans of Smoked Silver Salmon Because of Possible Health Risk
02/16/2019 Food Recall

Smoked Alaska Seafoods, Inc. of Wasilla, AK is recalling all jars and cans of Smoked Silver Salmon in 6.5 oz. containers with the production code of AL81111133 on the bottom of the jar/can because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.

Nature’s Path Foods Recalls A Specific Production Run Of Envirokidz Choco Chimps, Gorilla Munch And Jungle Munch Cereals Due To Undeclared Gluten
02/16/2019 Food Recall

Today, Nature’s Path Foods announced a voluntary recall of a specific production run of EnviroKidz Choco Chimps, Gorilla Munch and Jungle Munch cereals for they may contain undeclared gluten (wheat and barley). People who have a wheat allergy, celiac disease or sensitivity to gluten and wheat should not consume the cereals with the BEST BEFORE DATE listed below due to potential adverse health effects. Nature’s Path is also removing any affected cereals from customer store shelves and warehouses.

Kingston Pharma, LLC Issues Voluntary Recall of All Lots of “DG™ Baby Gripe Water Due to Undissolved Ingredient, Citrus Flavonoid
02/15/2019 Food Recall

Kingston Pharma, LLC is voluntarily recalling all lots of “DG™ Baby Gripe Water herbal supplement with organic ginger and fennel extracts” to the consumer level due to the presence of an undissolved ingredient, citrus flavonoid.

Sid Wainer and Son Initiates Class 2 Recall for Jansal Valley Dukkah Due to Potential Glass Pieces
02/15/2019 Food Recall

Sid Wainer and Son of New Bedford, MA is voluntarily recalling Jansal Valley brand Dukkah in 2.5oz containers because of the potential of it containing glass pieces

Ottogi America, Inc. Expands Recall on Undeclared Egg in Products
02/13/2019 Food Recall

Ottogi America, Inc. announced today it is expanding its recall to include the two items below due to a possibility of containing egg ingredient undeclared on the packages. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction of they consume these products.

World Waters Issues Voluntary Recall of Select WTRMLN WTR Original 12 Packs Due To The Possible Presence of Soft Plastic Pieces. Company Urges Consumers to Check Packages Prior to Consumption
02/11/2019 Food Recall

World Waters, LLC is initiating a voluntary recall of certain lots of Cold Pressed Juice Watermelon WTRMLN WTR Original 12 packs due to the potential presence of soft plastic that may be loosely floating in some of the finished products

Birdseed Food Co. Issues Allergy Alert on Undeclared Cashews in Craft Granola Goldenola Turmeric & Ginger
02/09/2019 Food Recall

BIRDSEED FOOD CO. of Bend, OR is recalling Craft Granola Goldenola Turmeric & Ginger that was sold between the dates of 10/03/18 - 02/07/19, because it contains undeclared cashews. People who have an allergy or severe sensitivity to cashews run the risk of serious or life-threatening allergic reaction if they consume this product.

McDaniel Life-Line LLC Issues Voluntary Worldwide Recall of Indian Herb
02/08/2019 Food Recall

Felt, OK, McDaniel Life-Line LLC is voluntarily recalling all lots of Indian Herb to the consumer level. This product is being recalled because it is marketed without an approved NDA/ANDA. The therapeutic claims made in the labeling for this product establish that it is a drug because it is an article (other than food) intended to affect the structure or any function of the body. Additionally, the product contains ingredients that the Agency has determined to be caustic in nature that can cause serious injury.

Frito-Lay Issues Voluntary Allergy Alert on Undeclared Milk In Small Number of Stacy’s Simply Naked Pita Chips
02/05/2019 Food Recall

Frito-Lay announced a limited voluntary recall of a very small number of 7 1/3 oz. bags of Stacy’s Simply Naked Pita Chips because they may contain undeclared milk ingredients. People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume the product contained inside the recalled pita chips bags.

Allergy Alert Issued by Santa Rosa Whole Foods Market for Undeclared Walnut, Milk and Eggs in “Hipster Chipster” Cookies
02/05/2019 Food Recall

The Santa Rosa Whole Foods Market store is voluntarily recalling eight packages of its “Hipster Chipster” cookies because they contain undeclared tree nut (walnut), milk, and egg allergens that were not listed on the product label.

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling
02/04/2019 Food Recall

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced that it’s wholly owned subsidiary, Dr Reddy’s Laboratories, Inc is continuing its voluntary nationwide recall of lot ABD807 of Levetiracetram in 0.54% Sodium Chloride Injection, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags to the hospital level in U.S.A.

Stryker Launches Voluntary Field Action for Specific Units of the LIFEPAK® 15 Monitor/Defibrillator
02/01/2019 Food Recall

The company is notifying certain LIFEPAK 15 customers of an issue that may cause the device to lock up after a defibrillation shock is delivered. The lock-up condition is defined as a blank monitor display with LED lights on, indicating power to the device, but no response in the keypad and device functions. A device in this condition has the potential to delay delivery of therapy, and this delay in therapy has the potential to result in serious injury or death.

Hill’s Pet Nutrition Voluntarily Recalls Select Canned Dog Food for Excessive Vitamin D
01/31/2019 Food Recall

Hill’s Pet Nutrition is voluntarily recalling select canned dog food products due to potentially elevated levels of vitamin D. While vitamin D is an essential nutrient for dogs, ingestion of elevated levels can lead to potential health issues depending on the level of vitamin D and the length of exposure, and dogs may exhibit symptoms such as vomiting, loss of appetite, increased thirst, increased urination, excessive drooling, and weight loss. Vitamin D, when consumed at very high levels, can lead to serious health issues in dogs including renal dysfunction. Pet parents with dogs who have consumed any of the products listed and are exhibiting any of these signs should contact their veterinarian. In most cases, complete recovery is expected after discontinuation of feeding.

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen
01/30/2019 Food Recall

Monmouth Junction, NJ, Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.

Nature’s Rx Issues Voluntary Nationwide Recall of Silver Bullet 10x to Undeclared PDF-5 Inhibitors in the Product
01/30/2019 Food Recall

Nature’s Rx is voluntarily recalling quantity lots of Silver Bullet 10x, description of dosage form to the hospital, retail or consumer level. This recall has been initiated because the product was found to contain undeclared sildenafil and tadalafil, the active ingredient in Viagra and Cialis respectively, which are PDE-5 inhibitors. The undeclared PDE-5 inhibitors in the product may pose serious health risks because consumers with underlying medical issues may take the products without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking

Purina Animal Nutrition Voluntarily Recalling Purina® Honor® Show Chow® Showlamb Grower Due to Elevated Copper Level
01/29/2019 Food Recall

)– Purina Animal Nutrition is voluntarily recalling two lots of Purina® Honor® Show Chow® Showlamb Grower due to elevated copper levels. The feed is packaged in purple branded Purina Honor Show Chow bags.

Oskri Organics Corporation Recalls All Nut Butters because of Possible Health Risk
01/29/2019 Food Recall

Oskri Organics Corporation of Lake Mills, WI is recalling ALL Oskri Corporation manufactured nut butters. This recall has been initiated due to positive test results for Listeria monocytogenes found in multiple Oskri Corporation manufactured nut butters.

SL: Recall of Thrive Market Nut Butters Due to Potential Health Risk
01/25/2019 Food Recall

Thrive Market, Inc, is recalling all unexpired lots of the Thrive Market-branded nut butters listed below (“Product(s)”) due to the potential for contamination with Listeria monocytogenes. On January 21, 2019, one of our suppliers notified us that it was issuing a recall of all nut butters it has manufactured since January 2018 because of a positive test for Listeria monocytogenes in recent lots. Because the safety of our members is our absolute priority, we are expanding on our supplier’s recall and are voluntarily recalling all unexpired lots of all Thrive Market-branded nut butters manufactured by this supplier.

Mrs. Grissom’s Salads Issues a Voluntary Recall
01/25/2019 Food Recall

For immediate release- January 18,2019 – Nashville, TN – Mrs. Grissom’s Salads is voluntarily recalling a single days production of Mrs. Grissom’s SELECT Old Fashioned Pimento Cheese because of a labeling issue. Product produced on December 13, 2018 may have been packaged incorrectly, with the correct Pimento Cheese label on top lid, but a Chicken salad label on the container. The Pimento Cheese may contain allergens not listed on the products ingredient label, Specifically Milk.

Jac. Vandenberg, Inc. Recalls Fresh Peaches, Fresh Nectarines and Fresh Plums Because They May Be Contaminted with Listeria Monocytogenes
01/25/2019 Food Recall

Jac. Vandenberg, Inc. of Yonkers, New York is recalling 1,727 cartons of Fresh Peaches, 1,207 cartons of Fresh Nectarines and 365 cartons of Fresh Plums because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Satur Farms’ Recall of Baby Spinach Affects Prepared Food Items from Whole Foods Market Stores in Eight States
01/25/2019 Food Recall

In response to a recall by Satur Farms, Whole Foods Market is voluntarily recalling various prepared foods items in eight states containing baby spinach because of a potential contamination of Salmonella.

Product Recall Because of Possible Health Risk
01/24/2019 Food Recall

Satur Farms, 3705 Alvah's Lane, Cutchogue, NY 11935 is voluntarily recalling Baby Spinach and Mesclun with the specific lot numbers listed below because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

General Mills Recalls Five Pound Bags of Gold Medal Unbleached Flour
01/24/2019 Food Recall

General Mills announced today a voluntary national recall of five-pound bags of its Gold Medal Unbleached Flour with a better if used by date of April 20, 2020. The recall is being issued for the potential presence of Salmonella which was discovered during sampling of the five-pound bag product.

Perrigo Issues Allergy Alert For Simple Truth Organic Banana, Strawberry & Apple Puree With Nonfat Greek Yogurt
01/24/2019 Food Recall

Perrigo Company, in coordination with The Kroger Company, is initiating a voluntary recall of one production lot of Simple Truth Organic Banana, Strawberry & Apple Fruit Puree with Nonfat Greek Yogurt (LOT L8159, best by 08/06/2019, produced in Spain) due to improper labeling that does not indicate the presence of milk, posing a potential risk to consumers with milk allergies.

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP
01/22/2019 Food Recall

Torrent Pharmaceuticals Limited is expanding its voluntary recall from 10 lots of Losartan potassium tablets USP to include 6 lots of Losartan potassium and hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

Ottogi America, Inc. Issues Allergy Alert on Undeclared Egg in Products
01/19/2019 Food Recall

Ottogi America, Inc. announced today it is recalling below 21 items due to a possibility of containing egg ingredient undeclared on the packages. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction of they consume these products.

Prinston Pharmaceutical Inc. issues Voluntary Nationwide Recall of Irbesartan and Irbesartan HCTZ Tablets Due to detection of a Trace Amount of Unexpected Impurity, N- nitrosodiethylamine (NDEA) in the Products
01/18/2019 Food Recall

-- Prinston Pharmaceutical Inc., dba Solco Healthcare LLC., has initiated a voluntary recall of one (1) lot of Irbesartan and seven (7) lots of Irbesartan HCTZ Tablets to the consumer level due to the detection of trace amount of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals.

RXBAR Recalls Certain Varieties of Bars Due to a Potential Undeclared Peanut Allergen
01/16/2019 Food Recall

RXBAR is voluntarily recalling certain varieties of bars because they may contain undeclared peanuts. People who have peanut allergies run the risk of serious or life-threatening allergic reaction if they consume this product.

Voluntary Recall Notice of El Guapo Chile Habanero and Chile Pasilla-Ancho Pouches Due to Unlabeled Peanut Allergen
01/16/2019 Food Recall

Mojave Foods Corporation is initiating a voluntary recall of El Guapo Chile Habanero and Chile Pasilla-Ancho pouches due to an unlabeled peanut allergen.

Happy Together, Inc. Issues Voluntary Nationwide Recall of Product Due to Presence of Undeclared Sildenafil and Tadalafil
01/08/2019 Food Recall

Happy Together, Inc. Boynton Beach, FL is voluntarily recalling all lots within expiry of the Rhino 5k capsules to the consumer level. FDA analysis founds these products to be tainted with sildenafil and Tadalafil. Sildenafil/Tadalafil is an FDA approved drug for the treatment of erectile dysfunction, the presence of sildenafil in the Rhino 5k products renders them unapproved drugs for which safety and efficacy have not been established, therefor subject to recall.

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass
01/08/2019 Food Recall

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder) to the hospital level. The Vecuronium Bromide for Injection has been found to contain particulate matter identified as glass.

Grand Strand Sandwich Company Recalls Lunch Box Sandwiches Italian Subs Lunch Box Sandwiches Ham & Swiss Croissants And Lunch Box Sandwiches Ham & Cheese Due To Possible Listeria Monocytogenes Contamination
01/08/2019 Food Recall

– Grand Strand Sandwich is recalling Lunch Box Italian Subs, Lunch Box Ham & Swiss Croissants and Lunch Box Ham & Cheese Frozen Wedges due to a potential contamination of Listeria Monocytogenes.

Hy-Vee Voluntarily Recalls Cheesecakes Made with Diamond Crystal Mix
01/07/2019 Food Recall

Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling its cheesecakes made with Diamond Crystal Brands cheesecake mix due to the potential that they may be contaminated with Salmonella. The potential for contamination was brought to Hy-Vee’s attention today after receiving a letter from the supplier. The voluntary recall includes 32 varieties of cheesecakes in both 8-ounce and 32-ounce packages with best if used by dates of Dec. 6, 2018, through Jan. 11, 2019. No illnesses have been reported to date.

Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g
01/05/2019 Food Recall

Lupin Pharmaceuticals, Inc. is voluntarily recalling 5 lots of Ceftriaxone for Injection, USP, 250mg, 10 lots of Ceftriaxone for Injection, USP, 500mg, 24 lots of Ceftriaxone for Injection, USP, 1g and 3 lots of Ceftriaxone for Injection, USP 2g, to the hospital/physician level. The products have been found to contain visual grey particulate matter in reconstituted vials.

Olde York Potato Chips Issues Allergy Alert on Undeclared Milk in One Lot of Clancy's Wavy Potato Chips 10 Oz
01/04/2019 Food Recall

Olde York Potato Chips of Brampton, Ontario is recalling Clancy's Wavy Potato Chips 10 oz (UPC 0 41498 16306 8) with the specific lot code BEST If Used By FEB 22 19 1A6 because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. No other lot codes and no other products are involved in this action.

Shamrock Farms Issues Voluntary Recall of 2% Reduced Fat Vanilla Half Gallon Milk Due to Undeclared Almonds
01/04/2019 Food Recall

Shamrock Farms of Phoenix, Arizona is issuing a voluntary recall of Shamrock Farms 2% Reduced Fat Vanilla Half Gallon Milk with Best Before Date 3/16/2019. The recall comes after a product retain of Shamrock Farms 2% Reduced Fat Vanilla Half Gallon Milk with Use By 03/16/19 Time Stamp 08:18-11:13 04-05 #1, tested positive for an undeclared tree nut (almond) allergen.

Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP
01/03/2019 Food Recall

Torrent Pharmaceuticals Limited is expanding its voluntary recall from 2 lots of Losartan potassium tablets USP to a total of 10 lots, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. Torrent is only recalling lots of losartan-containing products that contain N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA.

Results RNA LLC Issues Voluntary Worldwide/Nationwide Recall of Lubrisine Eye Drops Due to Manufacturing Sterility Concerns and Undeclared Colloidal Silver
01/03/2019 Food Recall

Results RNA LLC is voluntarily recalling Lubrisine Eye Drops to the healthcare practitioner, retail or consumer level. This product, in a recent FDA inspection, was found to be manufactured using practices that do not support its sterility and contained undeclared colloidal silver.

Oskri Organics Corporation Recalls Oskri Organic Sunflower Butter Lot #099, Oskri Tahini Butter Lot #193 and Thrive Sunflower Butter Lot #233 Because of Possible Health Risk
01/02/2019 Food Recall

Oskri Organics Corporation of Lake Mills, WI is recalling Oskri Organic Sunflower Butter Lot # 099, Oskri Tahini Butter LOT # 193 and Thrive Sunflower Butter LOT # 233, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 80 Lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP, Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity
01/01/2019 Food Recall

Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall.

Apio Inc. Expands Voluntary Recall of Eat Smart Salad Shake Ups Single-Serve Bowls
12/26/2018 Food Recall

Apio Inc. of Guadalupe, California is expanding a voluntary recall of Eat Smart Salad Shake Ups single-serve bowls. The recall comes after the Canadian Food Inspection Agency (CFIA) informed the company that another random sample of Eat Smart Salad Shake Ups Sweet Kale/Chou Frise Doux 156 gr. single-serve bowls (5.5oz) with Best Before Date of Dec 29, 2018, Lot 112 346, tested positive for Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Columbia River Natural Pet Foods Inc. Voluntarily Expands Recall to Include Cow Pie and Chicken & Vegetables Fresh Frozen Meats for Dogs and Cats Due to Possible Health Risk
12/24/2018 Food Recall

Columbia River Natural Pet Foods of Vancouver, WA is voluntarily expanding their current recall to include additional products: 261 packages of Cow Pie Lot # 72618 and 82 packages of Chicken & Vegetables Lot# 111518 fresh frozen meats for dogs and cats, produced in July 2018 and November 2018, due to their potential to be contaminated with Salmonella and Listeria monocytogenes

Funky Chunky, Llc Issues Allergy Alert on Undeclared Almond and Cashew Tree-Nut in 10 Oz. Nutty Choco Pop Found in Chocolate Popcorn Gift Box, Holiday Crowd Pleaser and Crowd Pleaser Gifts
12/21/2018 Food Recall

Funky Chunky, LLC of Eden Prairie, MN is recalling 10 oz Nutty Choco Pop Gift Box, 50 oz. Holiday Crowd Pleaser and 50 oz. Crowd Pleaser, because it may contain undeclared Almond and Cashew Tree Nut. People who have an allergy or severe sensitivity to Almonds and Cashews run the risk of serious or life-threatening allergic reaction if they consume these products.

Inspired Organics Issues Voluntary Recall of Organic Nut & Seed Butters Due to Potential Health Risk
12/20/2018 Food Recall

Inspired Organics, LLC has issued a voluntary recall of Organic Almond, Peanut, and Tahini Butters due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short- term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

Terrific Care, LLC. / Medex Supply Dist, Inc. issues Nationwide Recall of CoaguChek Test Strips
12/20/2018 Food Recall

On 12/19/2018, Terrific Care, LLC. / Medex Supply Dist, Inc. initiated a nationwide recall of Roche CoaguChek test strips distributed directly to U.S. consumers by Terrific Care, LLC. / Medex Supply Dist, Inc. The products have been found to inaccurately report high INR test results.

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP
12/20/2018 Food Recall

Torrent Pharmaceuticals Limited is voluntarily recalling 2 lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected in the API is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.

Fluoroquinolone Antibiotics: Safety Communication - Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain Patients
12/20/2018 Medical Recall

FDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta. These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death. They can occur with fluoroquinolones for systemic use given by mouth or through an injection.

Wegmans Issues Voluntary Recall of Fresh Cauliflower Rice, Veggie/Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower
12/19/2018 Food Recall

Rochester, NY – Wegmans Food Markets, Inc. has issued a voluntary recall of fresh Cauliflower Rice, Veggie Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower, sold in the produce department between 12/7/18 and 12/18/18, because it may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7). E. coli O157:H7 causes a diarrheal illness often with bloody stools. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called Hemolytic Uremic Syndrome (HUS). HUS is most likely to occur in young children and the elderly. The condition can lead to serious kidney damage and even death.

Gilenya (fingolimod): Drug Safety Communication - Severe Worsening of Multiple Sclerosis After Stopping the Medicine
11/20/2018 Medical Recall

FDA is warning that when the multiple sclerosis (MS) medicine Gilenya (fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being taken. This MS worsening is rare but can result in permanent disability.

Implanted Pumps: Safety Communication - Use Caution When Selecting Pain Medicine for Intrathecal Administration
11/14/2018 Medical Recall

The FDA is aware that patients undergoing treatment or management of pain are commonly given pain medicines in the spinal fluid (intrathecal administration) that are not FDA approved for use with the implanted pump.

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area
08/29/2018 Medical Recall

Requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.

Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers - Risk of Mortality and Stroke
08/17/2018 Medical Recall

FDA has reviewed the final results from the post-approval study conducted by SynCardia Systems, LLC. for their Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System). These final results indicate a higher mortality rate and higher stroke rate for patients initially supported with the C2 Driver System compared to patients initially supported with the previous generation driver, the Circulatory Support System (CSS) Console.

Risks Associated with Use of Rupture of Membranes Tests - Letter to Health Care Providers
08/08/2018 Medical Recall

The FDA is reminding health care providers that tests to detect rupture of the amniotic membranes should not be used without other clinical assessments to make critical patient management decisions.

Zithromax, Zmax (azithromycin): FDA Warning - Increased Risk of Cancer Relapse With Long-Term Use After Donor Stem Cell Transplant
08/03/2018 Medical Recall

The antibiotic Zithromax, Zmax (azithromycin) should not be given long-term to prevent a certain inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. Results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these patients.

Auvi-Q (epinephrine injection, USP): Recall - Potential Inaccurate Dosage Delivery
10/29/2015 Medical Recall

If a patient experiencing a serious allergic reaction (i.e., anaphylaxis) does not receive the intended dose, there could be significant health consequences, including death.

Entacapone: Drug Safety Communication - FDA Review Found No Increased Cardiovascular Risks
10/26/2015 Medical Recall

Drug labels for Comtan and Stalevo will remain unchanged.

  • Company:
    Stalevo
Hepatitis C Treatments Viekira Pak and Technivie: Drug Safety Communication - Risk of Serious Liver Injury
10/22/2015 Medical Recall

Cases of hepatic decompensation and liver failure in patients with underlying liver cirrhosis who were taking these medicines.

Alaris Medley Large Volume Pump (LVP) Frame Membrane by Elite Biomedical Solutions: Class I Recall - Frame Membrane May Allow Over or Under Delivery of Fluid by an Infusion Pump
08/27/2015 Medical Recall

Over or under infusion of fluids to the patient has the potential to cause patient injury or death.

Picato (ingenol mebutate) Gel: Drug Safety Communication - FDA Warns of Severe Adverse Events, Requires Label Changes
08/21/2015 Medical Recall

Severe allergic reactions, skin rashes, & cases of shingles (herpes zoster reactivation) reported. Severe eye injuries and skin reactions have occurred when Picato gel is not applied according to recommendations in the label.

  • Company:
    Picato
Implantable Left Ventricular Assist Devices (LVADs): FDA Safety Communication - Serious Adverse Events
08/05/2015 Medical Recall

Increased rate of pump thrombosis, high rate of stroke, bleeding complications.

HeartWare Ventricular Assist System Controllers by HeartWare International: Recall - Clinical Trial Controllers Susceptible to Electrostatic Discharge
02/27/2015 Medical Recall

Electrostatic discharge event could result in a pump stop, which could cause serious injury or death.

The Cultured Kitchen Voluntarily Recalls Cashew Cheese Due To Possible Risk Of Contamination From Salmonella
12/31/2013 Food Recall

The Cultured Kitchen of West Sacramento, CA is voluntarily recalling all flavors of their non-dairy cashew cheese product due to a risk of contamination from Salmonella. The non-dairy cashew cheese was distributed in Northern California and Nevada at various natural foods stores and farmers markets in the Sacramento Valley, San Francisco Bay Area, and Reno.

PENTAX Medical Company Issues Voluntary Nationwide Recall of OF-B194 Gas/ Water Valve
10/31/2013 Food Recall

On September 16, 2013 PENTAX Medical Company initiated a voluntary nationwide recall of 76 PENTAX Gas/ Water Valves, model OF-B194.The valves were offered as a separate purchase for use with PENTAX GI Video Endoscopes (90i/90k series and i10/k10 series).

  • Company:
    PENTAX Medical Company
Diabetes Treatments: FDA Alerts of Illegal Sales - Undeclared Ingredients
07/23/2013 Medical Recall

Some products may cause harm because they contain undeclared active drug ingredients or may not have been manufactured and handled according to FDA quality standards.

Zyprexa Relprevv (Olanzapine Pamoate): Drug Safety Communication - FDA Investigating Two Deaths Following Injection
06/18/2013 Medical Recall

Two patients died 3-4 days after receiving an appropriate dose of the drug. Posted 06/18/2013