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.
Ascend Laboratories is recalling 2,717 cartons of Dabigatran Etexilate Capsules, 150 mg, because stability testing found impurities above specification.
Ascend Laboratories is recalling 6,192 bottles of Amlodipine and Olmesartan Medoxomil tablets nationwide due to failed dissolution specifications and Olmesartan content below specifications.
Precision Dose Inc. is recalling Glycopyrrolate Oral Solution (1 mg/5 mL) because the product failed to meet specifications for impurities and degradation.
Bionpharma Inc. is recalling Divalproex Sodium Delayed-Release Tablets, 500 mg, because some bottles may contain foreign tablets or capsules.
FDA is recalling Xylocaine (lidocaine HCl) injections due to the presence of particulate matter, specifically hair found in the product.
Rising Pharma is recalling cyproheptadine hydrochloride syrup due to the presence of precipitate, including crystallization and floating particles in the bottle.
Asclemed USA Inc. is recalling 18 Lidolog Kits because the label wrap covers the barcode, making it hard to scan. The recall affects products distributed within the U.S. in Tennessee.
Supernus Pharmaceuticals is recalling Trokendi XR (topiramate) capsules because they failed dissolution specifications. The recall covers 15,853 bottles distributed nationwide.
Chiesi USA, Inc. is recalling Cleviprex (clevidipine) injectable emulsion due to lack of assurance of sterility. The affected product is distributed nationwide.
CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) applicators nationwide because affected units may have open or incomplete seals on the packaging, which could compromise sterility assurance.
Bell Pharmaceuticals is recalling Meijer Earwax Removal Kit (Carbamide Peroxide 6.5%) due to subpotency: the product contains significantly reduced active ingredient (~0.6% vs. expected ~6–7%) and low pH, limiting effectiveness.
CAREone Earwax Removal Drops (Carbamide Peroxide 6.5%) are recalled because the product contains significantly reduced active ingredient (~0.6% vs. expected ~6–7%) and low pH, making it ineffective.
Bell Pharmaceuticals is recalling Clinere Ear Wax Remover nationwide because the product contains significantly reduced active ingredient and low pH. The affected lots were distributed throughout the United States.
Bell Pharmaceuticals is recalling Quality Choice Earwax Removal Kit (Carbamide Peroxide 6.5%) due to subpotent drug content, with assay levels significantly reduced (approximately 0.6% versus expected 6–7%) and low pH levels.
Padagis US LLC is recalling Nystatin Cream USP (100,000 USP units) because long-term stability testing found assay results below specification, meaning the product may contain less active ingredient than labeled.
Bell Pharmaceuticals is recalling Leader Carbamide Peroxide 6.5% Earwax Removal Kit due to subpotency—the active ingredient is significantly reduced (approximately 0.6% versus the expected 6–7%) and the pH is low.
Bell Pharmaceuticals is recalling TopCare Earwax Removal Kit (Carbamide Peroxide 6.5%) because the drug is subpotent with significantly reduced active ingredient (~0.6% vs. expected 6–7%) and low pH. The affected product was distributed nationwide.
Bell Pharmaceuticals recalls Foster & Thrive Carbamide Peroxide 6.5% due to subpotent drug substance with low pH and significantly reduced assay levels. Approximately 31,094 units distributed nationwide are affected.
Family Wellness Carbamide Peroxide 6.5% earwax removal kits are being recalled because they are subpotent with low pH and significantly reduced active ingredient content (approximately 0.6% versus the expected 6–7%). Consumers should stop using affected lots and consult their pharmacist.
CVS Health Earwax Removal Drops are being recalled because the product contains significantly reduced active ingredient (approximately 0.6% instead of the expected 6–7%) and has low pH. The recalled product may not work as intended.
Bell Pharmaceuticals is recalling Good Neighbor Pharmacy Earwax Removal (Carbamide Peroxide 6.5%) due to subpotency—the active ingredient concentration is significantly reduced from expected levels, and the product has a low pH.
Bell Pharmaceuticals is recalling Audiologist's Choice Carbamide Peroxide earwax removal product due to subpotency: the active ingredient concentration is approximately 0.6% instead of the expected 6–7%, and the product has low pH.
Somerset Therapeutics is recalling Pemetrexed for Injection 100mg/Vial due to lack of sterility assurance. The recall affects approximately 12,000 vials distributed nationwide.
Reliance Life Sciences is recalling Pemetrexed for Injection 500mg/Vial nationwide due to lack of sterility assurance. The affected product may not meet required sterility standards for intravenous use.
Bortezomib for Injection 3.5mg/Vial manufactured by Reliance Life Sciences is being recalled nationwide due to lack of sterility assurance. Affected lots include RBIH0125A, RBIH0225A, RBIH0325A, and RBIH0525A distributed across the USA.
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