Recalls for Uncategorized

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.

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.

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

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).

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)

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.

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.

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

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

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.

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.

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.

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: 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.

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.

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/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

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

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

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

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

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

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.

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.

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.

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

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

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.

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.

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

2020 Medical Device Recalls
01/29/2020 Medical Recall

List of Medical Device recalls in 2020.

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.

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

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.

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).

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

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

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

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

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.

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.

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.

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.

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

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.

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.

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

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

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.

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.

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).

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

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.

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

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.

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