Category
FDA recalls of prescription and over-the-counter drugs.
FDA drug recalls cover prescription medicines, over-the-counter products, biologic and gene therapies, and active pharmaceutical ingredients (the raw drug substances that manufacturers compound into finished products). Recall classifications follow the same Class I / II / III system as food, and most published recalls are Class II — the product is unlikely to cause permanent harm but doesn't meet specification.
The most common reasons for a drug recall are out-of-specification potency or dissolution (the active ingredient is present in too high or too low a dose), microbial contamination, particulate matter in injectables, mix-ups during packaging where bottles end up with the wrong tablets, and nitrosamine impurities in certain drug classes. Many drug recalls are at the lot level — the manufacturer's whole product line is still safe to use, but specific production lots are pulled.
If a recall affects your medication: don't stop taking it on your own. Call your prescriber or pharmacist before doing anything. Stopping a prescribed drug abruptly can be more dangerous than the issue prompting the recall. Most drug-recall remedies route through the dispensing pharmacy, who'll either swap your supply for an unaffected lot or coordinate a refund with the manufacturer.
Direct Rx is recalling Ciprofloxacin Ophthalmic Solution 0.3% because the cap spike may lodge in the bottle nozzle, preventing the medication from being dispensed.
Somerset Therapeutics is recalling Haloperidol Decanoate Injection 50mg/mL vials nationwide due to lack of assurance of sterility from bacterial contamination detected in media fill testing.
Somerset Therapeutics is recalling Haloperidol Decanoate Injection (100 mg/mL, 1 mL vials) due to lack of assurance of sterility caused by bacterial contamination detected in media fill testing.
Somerset Therapeutics is recalling Methocarbamol Injection USP (1,000 mg/10 mL vials) nationwide due to lack of assurance of sterility following bacterial contamination in media fill testing.
Zydus Pharmaceuticals is recalling chlorpromazine hydrochloride 10 mg tablets due to the presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit. The recall affects 3,144 bottles distributed nationwide.
Alchemee, LLC is recalling Proactiv Skin Smoothing Exfoliator (Benzoyl Peroxide 2.5%) due to the presence of benzene, a known chemical contaminant.
Somerset Therapeutics is recalling 997 vials of Haloperidol Decanoate Injection 50mg/mL nationwide due to lack of assurance of sterility following bacterial contamination detected in a media fill validation test.
Somerset Therapeutics is recalling Haloperidol Decanoate Injection due to lack of assurance of sterility resulting from bacterial contamination detected during media fill testing. The recall affects 23,960 vials distributed nationwide.
Alchemee LLC is recalling Proactiv Emergency Blemish Relief (Benzoyl Peroxide 5%) due to the presence of benzene, a chemical contaminant. The recall affects approximately 38,237 bottles distributed nationwide.
Glenmark Pharmaceuticals is recalling Lacosamide 150mg tablets nationwide due to manufacturing quality deviations. Consumers should contact their pharmacy or healthcare provider regarding their supply.
Zydus Pharmaceuticals is recalling Venlafaxine 75 mg tablets due to a complaint of a metal shaving found embedded in a tablet. The recall affects 13,128 bottles distributed nationwide.
Glenmark Pharmaceuticals is recalling acetaminophen-ibuprofen tablets due to manufacturing quality deviations. No illnesses reported. Distributed nationwide via Amazon and Walmart.
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Lacosamide Tablets 50mg due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects specific lots distributed nationwide.
Glenmark Pharmaceuticals is voluntarily recalling Indomethacin Extended-Release Capsules (75mg) distributed nationwide due to Good Manufacturing Practice deviations identified during FDA oversight.
Glenmark Pharmaceuticals Inc. is recalling Pravastatin Sodium 20mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects specific lot numbers distributed across the U.S.
Glenmark Pharmaceuticals Inc., USA is recalling Metformin Hydrochloride Extended-Release Tablets 1000mg due to manufacturing practice deviations. The recall affects 90-count bottles distributed nationwide and is voluntary.
Glenmark Pharmaceuticals is voluntarily recalling Voriconazole tablets nationwide due to manufacturing process deviations. No illnesses or injuries have been reported.
Glenmark Pharmaceuticals is recalling Propafenone Hydrochloride Extended-Release Capsules 225mg (Lot #17230819) nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall is voluntary and initiated by the manufacturer.
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Fenofibrate Capsules 67 mg due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 100-count bottles distributed nationwide.
Glenmark Pharmaceuticals Inc. is recalling Colesevelam Hydrochloride 625mg tablets nationwide due to CGMP deviations. The firm initiated this Class II voluntary recall; no illnesses or injuries have been reported.
Glenmark Pharmaceuticals Inc., USA is recalling specific lots of Pravastatin Sodium Tablets 80mg due to Current Good Manufacturing Practice (CGMP) deviations. The recall applies to affected lots distributed nationwide and was initiated voluntarily by the firm.
Glenmark Pharmaceuticals Inc., USA is recalling Solifenacin Succinate 5mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall is voluntary and affects 30-count and 90-count bottles distributed across the U.S.
Glenmark Pharmaceuticals is recalling Saxagliptin 2.5mg tablets nationwide due to manufacturing quality issues. The firm initiated this voluntary recall on March 13, 2025.
Glenmark Pharmaceuticals is recalling Rufinamide 200mg tablets nationwide due to manufacturing process deviations. The voluntary recall affects certain lot numbers with July 2025 expiration dates.
Glenmark Pharmaceuticals Inc., USA is recalling Frovatriptan Succinate 2.5mg tablets nationwide due to current Good Manufacturing Practice (CGMP) deviations. The FDA has classified this as a Class II recall.
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