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.
Strides Pharma recalls Methoxsalen 10mg capsules (Lot #7253092B) due to failed dissolution specifications that could reduce medication effectiveness.
Sun Pharmaceutical is recalling Fexofenadine Hydrochloride 180mg tablets due to microbial contamination discovered in manufacturing equipment. Approximately 54,504 bottles distributed nationwide are affected by this Class II recall.
Sun Pharmaceutical recalls 6,552 bottles of Niacin Extended-Release Tablets (1000mg) nationwide due to microbial contamination in manufacturing equipment. No illnesses have been reported.
Sun Pharmaceutical is recalling Febuxostat 80 mg tablets due to microbial contamination in manufacturing equipment. Approximately 19,992 bottles were distributed nationwide.
IntegraDose Compounding Services recalled 281 syringes of Vasopressin 2 Unit/2 mL due to subpotency. The voluntary recall affects Lot #20230921VAS-2 distributed in Minnesota.
Sun Pharmaceutical recalls 9,408 bottles of Lurasidone Hydrochloride 120mg tablets nationwide due to microbial contamination discovered in manufacturing equipment.
BE Pharmaceuticals recalls Fosaprepitant for Injection nationwide due to failed aseptic process validation. The 22,176 vials from lot #13D012AA may lack sterility assurance.
SUN PHARMACEUTICAL INDUSTRIES is recalling 14,568 bottles of Zolpidem Tartrate Extended-Release 12.5mg tablets nationwide due to microbial contamination discovered in manufacturing equipment. Affected lot: DNE0893A (expires 07/31/2026).
Sun Pharmaceutical is recalling 1,728 bottles of Cinacalcet Tablets 60mg due to microbial contamination found in manufacturing equipment. No illnesses have been reported.
Sun Pharmaceutical recalls 55,272 bottles of Febuxostat 40mg tablets nationwide due to microbial contamination detected in manufacturing equipment. No illnesses have been reported.
Amerisource Health Services is recalling 6,344 cartons of Benzonatate 100 mg capsules nationwide due to assay results that were slightly above specification. No illnesses or injuries have been reported.
Sun Pharmaceutical is recalling approximately 1220 bottles of Zolpidem Tartrate Extended-Release 6.25 mg tablets distributed nationwide due to microbial contamination detected in manufacturing equipment.
Glenmark Pharmaceuticals is recalling Fluocinolone Acetonide Oil 0.01% ear drops due to failed excipient specifications. The affected lots nationwide do not meet required quality standards for isopropyl alcohol content.
Sun Pharmaceutical is recalling 11,400 bottles of Lurasidone Hydrochloride 60mg tablets due to microbial contamination in manufacturing equipment. Patients taking this medication should contact their doctor or pharmacist.
Sun Pharmaceutical is recalling Niacin Extended-Release Tablets nationwide due to microbial contamination found in manufacturing equipment. Affected lot numbers expire in June and July 2025.
Sun Pharmaceutical recalls 10,690 bottles of Mesalamine tablets nationwide due to microbial contamination found in manufacturing equipment. Patients should contact their healthcare provider.
The Procter & Gamble Company is recalling Secret antiperspirant/deodorant spray due to the presence of benzene, a chemical contaminant. The recall affects multiple lot numbers distributed nationwide and internationally.
The FDA is recalling Secret Dry Spray antiperspirant (Lot #12001458SF) due to benzene contamination. Consumers should stop using the product immediately.
Procter & Gamble is recalling Secret Dry Spray Antiperspirant due to benzene contamination in specific lot numbers. The FDA has classified this as a Class I recall.
Americaine benzocaine 20% topical anesthetic spray is being recalled nationwide due to benzene chemical contamination. The recall affects 34,704 cans with lot number 1A16420 and expiration date 01/31/2025.
Pfizer Inc. is recalling Atropine Sulfate Injection due to glass particulate matter contamination in lot GY2496. This FDA Class I recall affects 24,400 cartons distributed nationwide in the USA and Puerto Rico.
Pfizer is recalling 34,000 cartons of 4.2% Sodium Bicarbonate Injection nationwide due to glass particles in the solution. Patients should immediately stop use and contact their supplier.
Old Spice Sweat Defense Pure Sport Plus anti-perspirant spray is being recalled nationwide due to benzene contamination in specific lot numbers. Consumers should discontinue use of affected products immediately.
Old Spice Sweat Defense Ultimate Captain anti-perspirant spray is being recalled due to benzene contamination. The FDA Class I recall affects products distributed nationwide and internationally.
Old Spice PURE SPORT Anti-Perspirant Spray is recalled for benzene contamination in certain lot numbers. The product was distributed nationwide and internationally.
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