Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities…
Read More
AHF Recall Watch brings current food, medicine, meat and poultry, pet and animal, and public health recall information together in one place. The feature regularly checks official FDA and USDA sources for new and updated alerts, then organizes them so readers can quickly see what products are affected and why.
Use the filters below to search recent recalls by category or area. Each listing includes a link to the original government notice for complete details, affected products, distribution information and recommended actions.
Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC…
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Read MoreMycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505…
Presence of precipitate
Read MoreDorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL – bottle, Rx only, Manufactured by: Micro Labs Limited, India, Manufactured for: Micro Labs…
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Read MoreDabigatran Etexilate Capsules, 150 mg, 60-count (6×10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed…
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities…
Read MoreRohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard…
Lack of Assurance of Sterility
Read MoreLevothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by:…
Subpotent Drug
Read MoreRohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company,…
Lack of Assurance of Sterility
Read MoreLevothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by:…
Subpotent Drug
Read MoreTrokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc.,…
Failed Dissolution Specifications
Read MoreLevothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by:…
Subpotent Drug
Read MoreCORE Annual Reports
CORE Annual Reports summarize the adverse events and outbreaks linked to FDA-regulated foods investigated by the CORE Network by calendar…
Read MoreOutbreak Investigation of Listeria monocytogenes – Hispanic-style Fresh and Soft Cheeses (February 2021)
The FDA, along with CDC and state and local partners, are investigating a multistate outbreak of Listeria monocytogenes infections potentially…
Read MoreOutbreak Investigation of Salmonella Thompson: Seafood (October 2021)
The FDA, along with CDC and state and local partners, investigated a multistate outbreak of Salmonella Thompson infections linked to…
Read MoreOutbreak Investigation of Listeria: Ice Cream (August 2023)
The FDA and CDC, in collaboration with state and local partners, are investigating an outbreak of Listeria monocytogenes infections potentially…
Read MoreOutbreak Investigation of Salmonella: Cucumbers (June 2024)
Outbreak Investigation of Salmonella: Cucumbers (June 2024)
Read MoreOutbreak Investigation of Salmonella: Flour (April 2023)
Outbreak Investigation of Salmonella: Flour (April 2023)
Read MoreOutbreak Investigation of Hepatitis A Virus Infections: Frozen Strawberries (February 2023)
The FDA and CDC, in collaboration with state and local partners, are investigating an outbreak of hepatitis A virus infections…
Read MoreOutbreak Investigation of Salmonella: Raw Cookie Dough (May 2023)
Do not eat, sell, or serve Papa Murphy’s Chocolate Chip Cookie and S’mores Bars dough. FDA’s investigation is ongoing.
Read MoreOutbreak Investigation of Listeria monocytogenes: Enoki Mushrooms (November 2022)
FDA, along with CDC and state and local partners, is investigating an outbreak of Listeria monocytogenes infections linked to enoki…
Read More
