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.
Glenmark Pharmaceuticals is recalling Carvedilol 25 mg tablets nationwide due to a manufacturing quality issue with impurity levels exceeding FDA recommended limits. Multiple lot numbers and expiration dates from February 2025 through February 2026 are affected.
SKY PACKAGING is recalling HydrALAZINE Hydrochloride 50mg tablets nationwide due to failed impurities and degradation specifications. Four affected lot numbers have expiration dates from April 2025 to February 2026.
Glenmark Pharmaceuticals is recalling carvedilol tablets nationwide due to N-nitroso carvedilol I (NNCI-I), a carcinogenic impurity found in certain lots. The impurity exceeds FDA safety limits.
The FDA is recalling Potassium Chloride Extended-Release Tablets (10 mEq) distributed nationwide because they failed dissolution tests. This could affect how the medication is released in the body.
SKY Packaging recalls Hydralazine Hydrochloride 25 mg tablets nationwide due to failed quality specifications for impurities and degradation.
FDC Limited is recalling Timolol Maleate ophthalmic solution because the dropper cap spike may become lodged in the bottle nozzle, preventing access to the medication. The recall affects one lot distributed to a single U.S. distributor in New Jersey.
PAI Pharmaceutical Associates is recalling Guaifenesin and Codeine Phosphate Oral Solution because the product contains higher-than-labeled active ingredient concentrations. The affected product was distributed in Ohio.
Astellas Pharma recalls Prograf (tacrolimus) 0.5 mg capsules distributed nationwide due to empty capsules in bottles. Affected lot 0E3353D expires March 31, 2026.
Astellas Pharma is recalling Astagraf XL (tacrolimus) due to manufacturing defects; bottles shipped nationwide may contain empty capsules instead of medication.
McKesson is recalling Inflectra (infliximab-dyyb) injectable drug due to manufacturing quality deviations. A batch intended for quarantine was inadvertently distributed to patients nationwide.
Iovate Health Sciences is recalling Alpha Test 120-count capsules containing cathine, an unapproved ingredient not permitted in dietary supplements. Affected products were distributed across the United States and internationally.
Duloxetine Delayed-Release Capsules USP 20 mg are being recalled nationwide due to presence of nitrosamine impurity above FDA acceptable limits. No adverse events have been reported.
The W.S. Badger Company is recalling Badger 50 mineral sunscreen tins lacking the complete drug facts label, barcode, and directions for use. The recall affects 4,834 tins distributed nationwide.
Shoppers-Plaza is recalling FOUZEE SugarLin Herbal Formula capsules because FDA testing found undeclared metformin and glyburide. The product was marketed without FDA approval.
First Aid Beauty is recalling Ultra Repair Cream due to CGMP (Current Good Manufacturing Practice) deviations. Product intended for quarantine was inadvertently distributed nationwide.
Appco Pharma LLC is recalling Venlafaxine Extended-Release Tablets, 150mg, due to missing tablet identification imprints. The defect affects 1,380 bottles distributed nationwide.
Brands International Corporation is recalling Kissable Diabetics Foot Cream nationwide due to lack of adequate release testing during manufacturing. The FDA has classified this as a Class II recall.
Alcon Research is voluntarily recalling Systane Lubricant Eye Drops, Ultra PF, due to non-sterility concerns. The recall affects 55,960 boxes distributed nationwide.
Viatris Inc is recalling Cardura (doxazosin mesylate) XL 8 mg tablets due to failed stability testing revealing out-of-specification impurity levels. Approximately 1,215 bottles distributed nationwide are affected.
Amerisource Health Services LLC is recalling glipiZIDE Extended-Release Tablets, 2.5 mg, due to failed dissolution specifications. Patients should contact their pharmacist or healthcare provider.
Amerisource Health Services LLC is recalling Clobazam 10 mg tablets nationwide due to contamination with foreign tablets or capsules. Patients should contact their pharmacist or healthcare provider.
Akron Pharma recalls 768 bottles of Acetaminophen Extra Strength 500 mg due to incorrect identification imprinted on the tablets nationwide.
Viatris is recalling Cardura XL (doxazosin) 4 mg extended-release tablets nationwide due to out-of-specification impurity results detected during stability testing.
Akron Pharma is recalling 14,825 bottles of Acetaminophen 325 mg tablets due to incorrect tablet imprinting affecting lots KDT0124004, KDT0124005, and KDT0124006 (expiring August 31, 2026). No illnesses have been reported.
Akron Pharma is recalling 1,232 bottles of Acetaminophen Extra Strength tablets due to incorrect imprinting on the tablets. The product identification may be wrong on the affected tablets.
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