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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.
Dr. Reddy's Laboratories is recalling Javygtor powder packets nationwide due to powder discoloration and sub-potency. The recall affects 17,332 cartons with multiple lot numbers.
FDC Limited is recalling Timolol Maleate Ophthalmic Solution 0.5% distributed in New Jersey due to defective bottle caps with yellow spikes that can lodge in the nozzle, posing a risk of eye injury.
Breckenridge Pharmaceutical is recalling Duloxetine 60 mg capsules due to elevated levels of N-nitroso-duloxetine, a manufacturing impurity above FDA limits. No illnesses have been reported.
Sun Pharmaceutical is recalling Amphotericin B for Injection (50 mg vials) due to out-of-specification assay results. The recall affects 11,016 vials with lot numbers BAE0055A, BAE0056A, and BAE0068A distributed nationwide.
Advagen Pharma is recalling Tramadol Hydrochloride Tablets after a pharmacy discovered baclofen tablets mixed in a bottle of tramadol. This nationwide recall affects 2,592 bottles.
Breckenridge Pharmaceutical recalls Duloxetine 30mg delayed-release capsules nationwide due to N-nitroso-duloxetine impurity exceeding FDA-recommended interim limits. The impurity was identified as a CGMP manufacturing deviation.
Breckenridge Pharmaceutical recalls Duloxetine 20 mg capsules nationwide after detecting N-nitroso-duloxetine impurity above FDA-recommended limits in approximately 7,188 units from lot 220456, expiring February 2025.
RemedyRepack Inc. is recalling TraMADol HCl 50 mg tablets nationwide after a pharmacist discovered a baclofen tablet in a tramadol bottle. Taking the wrong medication poses serious health risks.
Aurobindo Pharma USA Inc. is recalling 6909 bottles of Clorazepate Dipotassium 7.5 mg tablets due to visible discoloration with yellow and dotted spots. No illnesses or injuries have been reported.
Acella Pharmaceuticals recalled 7,104 bottles of Sodium Sulfacetamide 10% Sulfur 5% Cleanser nationwide because the product contained less active ingredient than labeled. The recall was terminated in December 2025.
Kirkman 5-MTHF dietary supplement has a labeling error: the Supplement Facts incorrectly states 5000mcg Folic Acid per serving instead of 1000mcg. Lot# 477-0016, exp. 08/2025.
Aurobindo Pharma USA Inc. is recalling Clorazepate Dipotassium Tablets 3.75 mg due to yellow dots and discoloration on some tablets distributed nationwide.
Regeneron Pharmaceuticals recalled over 251,000 EYLEA (aflibercept) injection syringes distributed nationwide due to complaints of syringe breakage and concerns about sterility assurance in specific lots.
The FDA is recalling 3,320 bottles of compounded ophthalmic solution due to subpotency. The affected product does not contain adequate amounts of active medication.
Amneal Pharmaceuticals recalls Methylergonovine Maleate 0.2mg tablets nationwide due to failed dissolution specifications. The tablets may not dissolve properly, potentially reducing medication effectiveness.
Hikma Injectables USA Inc. has recalled 1,895 bags of Fentanyl 1000mcg/100mL injection (lot CH0324001) due to incorrect barcodes on the product labeling.
Imprimis NJOF, LLC is recalling epinephrine-lidocaine injectables nationwide because they failed to meet potency specifications. Patients should contact their healthcare provider regarding affected lots.
Viatris Inc is recalling 143,230 bottles of Valacyclovir Hydrochloride 500 mg tablets due to missing imprints on some tablets. The recall is nationwide and affects two lot numbers expiring in June 2024 and May 2025.
Alcoholada Gel pain reliever is being recalled because the ethanol ingredient contains methanol contamination. The FDA classified this as a Class I recall affecting 9,625 bottles distributed nationwide.
Pyramids Wholesale Inc. is recalling Silverback XXX Power male enhancement nationwide due to undeclared sildenafil and/or tadalafil. These prescription drugs were not approved by the FDA before marketing.
Spanish Fly 22K capsules contain undeclared sildenafil and/or tadalafil and were marketed without FDA approval. The product poses serious health risks from these unapproved pharmaceutical ingredients.
Pyramids Wholesale Inc. is recalling libigrow RED DRAGON+ capsules nationwide because they contain undeclared sildenafil and tadalafil, prescription medications not approved by the FDA for this product.
The GOAT Sublingual Strip male enhancement product, distributed nationwide, was recalled for containing undeclared sildenafil and tadalafil. The product was marketed without FDA approval.
Flower Power CBD infused Female Enhancement contains undeclared sildenafil and tadalafil. These prescription drugs were not disclosed to consumers and the product was marketed without FDA approval.
Pyramids Wholesale Inc. is recalling all lots of GoHARD 25000 because it contains undeclared sildenafil and tadalafil. The product was marketed without FDA approval for these prescription-strength drugs.
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