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.
Rising Pharma is recalling 868 tubes of Diflorasone Diacetate ointment because impurity levels failed to meet safety specifications during stability testing. No illnesses have been reported.
FDA is recalling 8,020 vials of Verapamil Hydrochloride Injection (Lot L300269) distributed nationwide due to potential cross contamination with other products.
Suntegrity IMPECCABLE SKIN sunscreen foundation is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The recall involves 8,202 tubes distributed nationwide and internationally.
Zydus Pharmaceuticals is recalling Micafungin for injection (100 mg/vial, Lot #L300220) due to potential cross-contamination with other products. Approximately 12,720 vials distributed nationwide in the USA and Puerto Rico are affected.
Zydus Pharmaceuticals recalls Micafungin for injection (Lot L300217) distributed nationwide due to potential cross contamination with other products. No illnesses have been reported.
Zydus Pharmaceuticals is recalling Verapamil Hydrochloride Injection vials nationwide due to potential cross contamination with other products.
To the Moon Capsules are being recalled nationwide because they contain undeclared sildenafil, a prescription pharmaceutical. The product was marketed without FDA approval.
Integrity Products recalls RAM IT Horny Goat Weed dietary supplement capsules nationwide because they contain undeclared sildenafil, a prescription drug not listed on the label.
Medisca Inc. is recalling 113 bottles of Budesonide, USP (Micronized) 500 mg due to glass particulate matter contamination caused by manufacturing deviations. The product was distributed nationwide in the USA and Canada.
Sun Pharmaceutical is recalling Decitabine for Injection (lot HAD2964A, 2,088 vials) for a Current Good Manufacturing Practice deviation. The Total Aerobic Microbial Count test on unfiltered bulk was out of specification; the product was distributed nationwide.
Little Moon Essentials voluntarily recalls Dream Cream due to manufacturing quality control violations. No illnesses reported.
Dr. Reddy's Laboratories is recalling Allopurinol 300mg tablets due to the presence of a foreign substance. Approximately 20,520 units were distributed in Illinois, Mississippi, and Ohio.
Trigen Laboratories recalls Methylphenidate Hydrochloride Extended-Release Tablets (36mg) because a batch failed dissolution specifications. Approximately 10,448 bottles were distributed nationwide.
Little Moon Essentials has voluntarily recalled Vital Vapor Balm (camphor 0.6%, menthol 5.2%) due to Current Good Manufacturing Practice deviations. The Class II recall affects 1,041 units distributed nationwide in the United States and Canada.
Little Moon Essentials Aching Head Rub is being recalled by the manufacturer for manufacturing deviations. The voluntary recall affects 6,312 units distributed nationwide and in Ontario, Canada.
Little Moon Essentials Crampy Belly Rub, a camphor-based topical product, is being recalled nationwide and in Canada due to manufacturing deviations. The firm-initiated recall affects 788 glass jars.
Little Moon Essentials Asana Kisser, a topical product containing camphor and menthol, is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 320 units distributed in the United States and Canada.
The FDA is recalling Venlafaxine Hydrochloride extended-release capsules (37.5mg) distributed nationwide because routine stability testing revealed the capsules failed to meet dissolution specifications, potentially affecting drug effectiveness.
Accord Healthcare is recalling Dodex Injectable (Cyanocobalamin) due to subpotency; affected batches contain less active ingredient than labeled. Patients using affected lots should contact their healthcare provider.
Little Moon Essentials is recalling Magical Muscle Oil due to manufacturing practice deviations. The recall affects 1,654 glass jars distributed nationwide in the USA and Canada.
Little Moon Essentials Clear Breeze Plus Hand Sanitizer is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The product was distributed nationwide in the USA and Canada.
Little Moon Essentials is voluntarily recalling Ass Kisser due to CGMP deviations identified in the manufacturing process. The recall affects 165 metal tins distributed nationwide in the USA and Canada.
Dr. Reddy's Laboratories is recalling 13,752 bottles of Eszopiclone 1mg tablets due to failed impurity and degradation specifications. Lot C2302598 was distributed in Ohio and Mississippi.
Pfizer is recalling specific lots of Buprenorphine Hydrochloride Injection due to potential incomplete crimp seals that could compromise product sterility. Patients using affected lots should consult their healthcare provider.
Coast Quality Pharmacy is recalling Progesterone 200 mg compounded sublingual tablets nationwide due to discovery of broken metal pieces embedded in tablets. Patients should contact their healthcare provider.
Looking for a different category? Browse all recalls.