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.
AvKARE is recalling Chlorthalidone Tablets USP 25 mg due to failed dissolution specifications. The defect may affect the drug's therapeutic effectiveness.
Glenmark Pharmaceuticals Inc., USA is recalling Ezetimibe and Simvastatin Tablets (10mg/40mg) due to out-of-specification results for related substances in a stability study. The recall affects approximately 6,759 bottles distributed nationwide.
Macleods Pharmaceuticals is recalling Levothyroxine Sodium 112 mcg tablets (Lot #MLF2401A, expiration 01/31/2026) distributed nationwide due to black hair found embedded in tablets.
Torrent Pharma Inc. is recalling Fluoxetine Tablets, USP, 20 mg in a 28-count carton due to the presence of N-Nitroso Fluoxetine exceeding the interim acceptable intake limit.
Torrent Pharma Inc. is recalling Fluoxetine Tablets USP 20 mg due to the presence of N-Nitroso Fluoxetine exceeding the interim acceptable intake limit. The affected lot is distributed nationwide.
Apotex Corp. is recalling Lacosamide Oral Solution because certain bottles may leak when stored horizontally. Patients taking this seizure medication should contact their pharmacy or healthcare provider.
Spectrum Advanced Gel Hand Sanitizer (70% ethyl alcohol, 8 FL OZ) has been recalled nationwide because affected batches contain cloudy appearance and test below the claimed 70% alcohol concentration, making them less effective.
Amerisource Health Services LLC is recalling Indomethacin Extended-Release Capsules 75 mg due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 21 cartons distributed nationwide.
Glenmark Pharmaceuticals is recalling Carvedilol Tablets USP 25 mg nationwide due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit, resulting from CGMP deviations.
Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets USP 3.125mg due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit. The recall affects 100-count and 500-count bottles distributed nationwide.
Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets USP 12.5 mg due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit, resulting from current Good Manufacturing Practice (CGMP) deviations.
Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets USP 6.25 mg due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit. The recall affects 100-count and 500-count bottles distributed nationwide.
VEPEMVA Nutrition's Endurance Boost with Horny Goat Weed has been recalled because it contains Sildenafil and Propoxyphenylsildenafil, undisclosed active pharmaceutical ingredients. The product was marketed and sold without FDA approval.
Alembic Pharmaceuticals Limited is recalling Bromfenac Ophthalmic Solution 0.09% nationwide due to failed impurities and degradation specifications. Three affected lots expire May 31, 2025.
Glenmark Pharmaceuticals is recalling Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, due to out-of-specification results on dissolution testing. The recall affects 8,520 bottles distributed nationwide.
Zydus Pharmaceuticals is recalling Esomeprazole Magnesium 40 mg delayed-release oral suspension because out-of-specification test results were found for unknown degradation products during stability testing.
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators nationwide because affected units may have open seals on the packaging, compromising sterility assurance.
AstraZeneca is recalling AIRSUPRA (albuterol sulfate and budesonide) inhalation aerosol due to a defective delivery system. The recall affects multiple lot numbers and expiration dates distributed nationwide.
Rapidol Triple Antibiotic First Aid Ointment (Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate) distributed in Delaware and North Carolina is being recalled for CGMP deviations. The manufacturer initiated a voluntary recall of 9,336 tubes.
Nature Mint Anticavity Fluoride Toothpaste (0.76% sodium monofluorophosphate, 2.75 OZ tube) is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The affected lots were distributed in Delaware and North Carolina.
Maximum Security Anticavity Gel Toothpaste is being recalled due to Current Good Manufacturing Practice (CGMP) deviations identified by the manufacturer. The recall affects toothpaste tubes distributed in Delaware and North Carolina.
KENIL HEALTHCARE PRIVATE LIMITED is recalling Maximum Security Anticavity Gel Toothpaste sachets distributed in Delaware and North Carolina due to Current Good Manufacturing Practice (CGMP) deviations identified by the FDA.
KVK Tech, Inc. is recalling 9,680 bottles of Phentermine Hydrochloride Capsules 30mg nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall is voluntary and firm-initiated.
KOFAL Athletes Penetrating Pain Relief external analgesic ointment (methyl salicylate 10.5%) is being recalled due to CGMP deviations in manufacturing. The voluntary recall affects 11,808 jars distributed in Delaware and North Carolina.
KENIL HEALTHCARE PRIVATE LIMITED is recalling KOFAL Original Penetrating Pain Relieving Ointment (methyl salicylate 12%) due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 16,248 jars distributed in Delaware and North Carolina.
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