Recalls, Market Withdrawals, & Safety Alerts
The list below provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products. Not all recalls have press releases or are posted on this page. See Additional information about recalls for a more complete listing.
The Recalls, Market Withdrawals & Safety Alerts are available on FDA’s website for three years before being archived. To search archived content, visit Search FDA Archive and input the name of the product and/or company name in the Search terms box as well as the year to get the most inclusive search results. To scroll through archived Recalls, Market Withdrawals & Safety Alerts content by year, see the Recall and Safety Alerts Archive.
Sign up to receive Recalls, Market Withdrawals and Safety Alerts.* FDA Employees: Use Chrome to Subscribe until further notice.
| Date | Brand Name(s) | Product Description | Product Type | Recall Reason Description | Company Name | Terminated Recall | Excerpt |
|---|---|---|---|---|---|---|---|
| Multiple brand names | All FDA-regulated products held at facility including drugs, medical devices, cosmetics, dietary supplements, human food, and pet food | Animal & Veterinary, Foodborne Illness, Cosmetics, Foodborne Illness, Dietary Supplements, Foodborne Illness, Drugs, Foodborne Illness, Food & Beverages, Foodborne Illness, Medical Devices, Foodborne Illness | Potential Salmonella contamination, presence of rodent and avian contamination and insanitary conditions during the storage process. | Gold Star Distribution, Inc. | … SKU Description UPC SKU Description UPC 01G PANAX GINSENG GREEN 30CT 799745282023 16OSF1 GOLDIVA … SHOT 4.2oz/10CT 16OSF2 GOLDIVA SUNFLOWER OIL 3L/6CT 01H MIRACLE HONEY 12CT 869036000404 16PBC JIF PEANUT BUTTER … 16FP1 POST COCOA PEBBLES 12/11 oz 884912129512 16G1 2ND FOODS BANANA 8 (2 -4oz) 12202017 015000076054 16G2 2ND FOODS … | ||
| No Brand | Ham & Cotija Torta Sandwich on Telera Roll | Food & Beverages | Potential Listeria monocytogenes contamination. | MG Foods | … No Brand … MG Foods … Melbourne, Fla. (February 13, 2024) - MG Foods is … | ||
| Lupin | Quinapril 20 and 40 mg tablets | Drugs | Presence of nitrosamine impurity, N-Nitroso-Quinapril | Lupin Pharmaceuticals Inc. | Terminated | … Lupin … Lupin Pharmaceuticals Inc. … Baltimore, Maryland, December 21, 2022: Lupin Pharmaceuticals Inc. is voluntarily recalling four (4) lots of Quinapril Tablets to the patient … in September 2022. Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and … | |
| Pfizer | Accupril (Quinapril HCl) tablets 10mg, 20mg, 40 mg | Drugs | Due to N-Nitroso-Quinapril Content | Pfizer | Terminated | … Pfizer … Pfizer … FOR IMMEDIATE RELEASE - NEW YORK, NY., April 22,2022. Pfizer is voluntarily recalling five (5) lots of Accupril (Quinapril HCl) tablets … Intake (ADI) level. Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and … | |
| CHANTIX | Varenicline tablets | Drugs | N-nitroso-varenicline above acceptable daily intake level | Pfizer | … CHANTIX … Pfizer … Pfizer is voluntarily recalling all lots of Chantix 0.5 mg and 1 mg Tablets to the patient (consumer/user) level due … in varenicline. Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and … | ||
| CHANTIX | Smoking cessation treatment | Drugs | N-Nitroso Varenicline content above ADI level | Pfizer | … CHANTIX … Pfizer … Pfizer is voluntarily recalling two lots of Chantix 0.5mg Tablets, two lots of Chantix 1 mg Tablets, and eight lots … in varenicline. Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and … | ||
| Fresh to You, MG Foods | Turkey wrap sandwich wraps | Food & Beverages | Due to possible Listeria monocytogenes | MG Foods dba Canteen Inc. | … Fresh to You … MG Foods … MG Foods dba Canteen Inc. … MG Foods of Charlotte, NC is … | ||
| Time-Cap Labs Inc. | Metformin Hydrochloride for Extended-Release Tablets, USP 500 mg and 750 mg | Drugs | Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity | Marksans Pharma Limited | Terminated | … Time-Cap Labs Inc. … Marksans Pharma Limited … Marksans Pharma Limited, India is voluntarily expanding its earlier initiated recall on June 05, 2020 to include … is a known environmental contaminant found in water and foods, including meats, dairy products and vegetables. … | |
| Riomet ER | Metformin Hydrochloride for Extended-Release Oral Suspension | Drugs | Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity | Sun Pharmaceutical Industries | Terminated | … Riomet ER … Sun Pharmaceutical Industries … Sun Pharmaceutical … Sun Pharmaceutical Industries Ltd. is voluntarily recalling one lot of RIOMET ER™ (metformin hydrochloride for … is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. To … | |
| Bayshore Pharmaceuticals, LLC | Metformin Hydrochloride Extended-Release Tablets USP, 500 mg & 750 mg | Drugs | Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity | Bayshore Pharmaceuticals, LLC | … Bayshore Pharmaceuticals, LLC … Bayshore Pharmaceuticals, LLC … Bayshore … LLC, Short Hills, NJ is voluntarily recalling one (1) lot of Metformin Hydrochloride Extended-Release … is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. … |