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.
Safecor Health is recalling certain Vitamin B1 supplements due to manufacturing defects where blister card-foils are separating from the blister cavity.
Dr. Reddy's Laboratories is recalling ibuprofen 600 mg tablets for failed tablet specifications. The affected product was distributed nationwide.
Trinity Gold Nutrition capsules (Lot IN-030, expiring November 2027) have been recalled for containing three undeclared pharmaceutical ingredients: acetaminophen, diclofenac, and phenylbutazone. These unapproved drugs could cause health risks through medication interactions and adverse effects.
Cipla USA is recalling Lanthanum Carbonate Chewable Tablets (1000mg) distributed nationwide due to complaints of crushed and broken tablets that fail manufacturing specifications.
Hydralazine HCl Tablets 25mg are recalled nationwide due to failed impurities and degradation specifications. The recall affects approximately 25,814 tablets distributed by Avet Pharmaceuticals and MAJOR Pharmaceuticals.
Cipla USA is recalling Lanthanum Carbonate Chewable Tablets, 1000mg due to complaints of crushed and broken tablets. The recall affects 1,875 boxes distributed nationwide.
Keystone Industries is recalling Perio Maintenance Rinse due to subpotency—the stannous fluoride concentration is below specifications. Affected lots were distributed nationwide.
Staska Pharmaceuticals recalled ascorbic acid injectable solution due to glass contamination. The FDA classified the recall as Class I; 4,773 vials nationwide were affected.
Direct Rx is recalling 1,410 bottles of Ibuprofen 800mg tablets distributed nationwide due to failed impurity specifications discovered during 18-month stability testing.
FDC Limited is recalling 155,232 bottles of Timolol Maleate Ophthalmic Solution due to a defective cap spike that becomes lodged in the nozzle, preventing medication dispensing.
Baxter Healthcare Corporation is recalling 60,594 units of Regadenoson Injection nationwide due to missing label information on affected lot numbers. Healthcare providers with affected lots should contact the manufacturer for replacement supplies.
Dr. Reddy's Laboratories is recalling Morphine Sulfate Extended-Release Tablets 15 mg nationwide due to failed impurity and degradation specifications. Patients taking affected lots should contact their healthcare provider immediately.
Dr. Reddy's Laboratories is recalling Morphine Sulfate Extended-Release Tablets 30 mg (Lot FG13996) nationwide due to failed impurities and degradation specifications.
Viona Pharmaceuticals is recalling Dapsone Gel 7.5% due to crystallization. The voluntary recall covers 6,048 pumps distributed nationwide in the United States.
Denison Pharmaceuticals is recalling its Maximum Strength Cough and Chest Congestion medication due to crystallization in bottles. The product, distributed by Genexa Inc., may contain chunks, graininess, or crystal substances that affect uniformity.
Denison Pharmaceuticals recalls Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo Pack due to crystallization and texture changes in affected bottles.
Dr. Reddy's Laboratories is recalling Cinacalcet 60 mg tablets nationwide because testing detected N-nitroso impurity exceeding FDA interim limits. The recall affects 35,880 bottles.
Dr. Reddy's Laboratories recalls Cinacalcet 30 mg tablets nationwide due to manufacturing defects that produced N-nitroso impurity above FDA recommended limits. Patients should contact their healthcare provider if they are taking an affected lot.
Accord Healthcare is recalling Cinacalcet 90 mg tablets nationwide due to nitrosamine impurity (N-nitroso-cinacalcet) at levels exceeding the FDA's acceptable daily intake limit. The issue stems from manufacturing process deviations.
Accord Healthcare recalls Cinacalcet 60mg tablets nationwide because N-nitroso-cinacalcet impurity was detected above acceptable daily intake limits. The contamination resulted from manufacturing process deviations.
Accord Healthcare is recalling Cinacalcet 30mg tablets nationwide due to a nitrosamine impurity (N-nitroso-cinacalcet) exceeding acceptable daily intake limits. Patients should consult their healthcare provider to confirm if their medication is affected.
Dr. Reddy's Laboratories is recalling Cinacalcet 90 mg tablets due to N-nitroso impurity exceeding FDA limits. Patients should contact their healthcare provider.
BLI International is recalling Chlorpheniramine Maleate 4 mg tablets because the product failed stability testing, showing increased potency beyond specified limits. The recall affects 4,901 cases distributed to customers in Ohio and Missouri.
AK Forte Ortiga y Omega 3 tablets are recalled nationwide for containing undeclared diclofenac and acetaminophen without FDA approval. Consumers should stop using this product immediately.
Fresenius Kabi Compounding recalled phenylephrine HCl injectable due to cGMP violations. The recall affects 2,756 doses distributed to 125 direct accounts nationwide.
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