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.
Mylan Institutional is recalling Levothyroxine Sodium tablets nationwide due to subpotent and superpotent units. Patients taking affected tablets may receive incorrect doses of this thyroid medication.
Mylan Institutional recalls 1,133 cartons of Levothyroxine Sodium Tablets (137 mcg) nationwide. Three lots contain subpotent and superpotent tablets.
Viatris Inc recalls 92,512 bottles of Levothyroxine Sodium tablets with potency failures—some are stronger than intended, others are weaker than intended.
DesBio lunaSOMM Natural Sleep Support Dietary Supplement is recalled due to undeclared soy lecithin. The product is labeled as containing sunflower lecithin but contains soy lecithin, posing a risk to consumers with soy allergies.
Mylan Institutional recalls 690 cartons of Levothyroxine Sodium 150 mcg tablets nationwide due to potency variation. Some units may be subpotent or superpotent.
FDC Limited is recalling Timolol Maleate eye drops (0.25%, 15mL bottles) due to a defective cap design where the spike may lodge in the bottle nozzle, preventing patients from dispensing the medication.
Viatris Inc is recalling 35,883 bottles of Levothyroxine Sodium Tablets (112 mcg) distributed nationwide due to potency failures. Some tablets contain too much active ingredient (superpotent) and others too little (subpotent). No illnesses have been reported.
Dr. Reddy's Laboratories is recalling 7,233 bottles of JAVYGTOR (sapropterin dihydrochloride) tablets nationwide because the medication failed specifications for impurities and degradation products. Affected patients should contact their healthcare provider.
LNK International recalls Kirkland Severe Cold & Flu Plus Congestion due to Current Good Manufacturing Practice (CGMP) deviations. The product should not have been released and was distributed to wholesale customers.
ZapMax Capsules, 500 mg are recalled for containing undeclared sildenafil and diclofenac without FDA approval. The product was distributed nationwide; consumers should stop using immediately and consult their healthcare provider.
PeakMax Capsules contain undeclared sildenafil and diclofenac and were marketed without FDA approval. This Class I recall affects capsules distributed nationwide.
VitalityXtra Capsules containing undeclared sildenafil and diclofenac are being recalled nationwide. The product was marketed without required FDA approval and poses health risks from undeclared pharmaceutical ingredients.
ZoomMax Capsules have been recalled by the FDA due to containing undeclared sildenafil and diclofenac. The product was marketed without FDA approval.
American Regent, Inc. is recalling specific lots of Venofer (iron sucrose) injection due to potential glass delamination in vials. The intravenous drug distributed nationwide may contain particulate matter.
Aurobindo Pharma USA is recalling Cinacalcet 30mg tablets nationwide due to N-nitroso Cinacalcet impurity above FDA limits. Patients should contact their healthcare provider about their medication.
AvKARE is recalling Sunitinib Malate 25 mg capsules nationwide due to a label mix-up in lot 100049501. The FDA has classified this as a Class II recall.
AvKARE is recalling Cinacalcet Tablets 30 mg due to nitrosamine impurity levels exceeding safe limits. Affected bottles nationwide should not be used.
Glenmark Pharmaceuticals is recalling 4,704 bottles of Diltiazem Hydrochloride extended-release capsules 90mg due to manufacturing contamination with an impurity above FDA limits. Two lot numbers distributed nationwide are affected.
Accord Healthcare is recalling Levothyroxine Sodium 75 mcg tablets (Lot D2300191, expiring 12/31/2025) distributed nationwide due to subpotency. Affected patients should contact their healthcare provider.
Rising Pharma recalls Duloxetine Delayed-Release Capsules 20 mg nationwide due to N-nitroso-duloxetine impurity exceeding recommended interim limits, affecting 209,376 bottles.
Glenmark Pharmaceuticals is recalling Diltiazem Hydrochloride capsules because they contain a chemical impurity above safe limits. About 7,296 bottles were distributed nationwide.
Armonia Natural Store LLC is recalling OneMultivitaminic GAF-PLUS Advance 300ml for containing undeclared Acetaminophen, Dexamethasone Phosphate, and Aspartame. Consumers should discontinue use immediately.
Midlab Incorporated is recalling ROYALAB Germ Away Antibacterial Hand Soap (1-gallon, Lot 0711241) due to out-of-specification microbiological test results. The product failed manufacturing quality standards.
Glenmark Pharmaceuticals recalls Diltiazem Hydrochloride extended-release capsules due to presence of N-nitroso-desmethyl-diltiazem impurity above FDA recommended limits. The recall affects 12,864 bottles distributed nationwide.
Lannett Company is recalling 1,608 bottles of Lisdexamfetamine Dimesylate 10 mg capsules nationwide due to failed content uniformity. The active ingredient may be unevenly distributed in some capsules.
Looking for a different category? Browse all recalls.