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.
Major Pharmaceuticals is recalling Levothyroxine Sodium Tablets, 112 mcg, lot N02203, due to subpotent drug concerns. The recall affects nationwide U.S. distribution and was initiated voluntarily by the firm.
Major Pharmaceuticals is recalling Levothyroxine Sodium Tablets, 25 mcg, lot N02212, due to subpotency. The recall is nationwide and voluntary.
Rohto-Mentholatum is recalling 972,001 cartons of ROHTO DRY-AID sterile eye drops due to lack of assurance of sterility. The recall affects lots distributed nationwide in the U.S.
Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling ROHTO Cooling Eye Drops due to a lack of assurance of sterility. The recall affects multiple lots distributed nationwide within the United States.
Major Pharmaceuticals is voluntarily recalling Levothyroxine Sodium Tablets, 75 mcg, NDC 0904-6951-61, due to subpotency. The recall affects lots N02172, N02296, and N02288 with expiration dates in July and December 2026, distributed nationwide.
Major Pharmaceuticals is recalling Levothyroxine Sodium Tablets, 88 mcg, lot N02310, due to subpotency. The recall is voluntary and affects nationwide distribution in the USA.
Major Pharmaceuticals is voluntarily recalling Levothyroxine Sodium 125 mcg tablets (Lot N02266, Exp. 11/2026) nationwide due to subpotency, meaning the tablets may contain less active ingredient than labeled.
Major Pharmaceuticals is recalling Levothyroxine Sodium Tablets, 25 mcg, due to subpotency. The recall affects nationwide U.S. distribution of specific lot numbers.
Modern Warrior Life, LLC is recalling Modern Warrior Ready dietary supplements because they contain unapproved ingredients including tianeptine, 1,4 DMAA, and aniracetam.
Major Pharmaceuticals is recalling Levothyroxine Sodium Tablets, 50 mcg, due to subpotency. The recall affects nationwide distribution in the USA and involves specific lot numbers.
Rohto Digi-Eye cooling eye drops are recalled due to a lack of assurance of sterility. The recall affects 65,219 cartons distributed nationwide in the U.S.
The FDA is recalling ROHTO OPTIC GLOW sterile eye drops due to a lack of assurance of sterility. The recall affects 1,278,457 cartons distributed nationwide in the U.S.
Rohto-Mentholatum is recalling ROHTO Cooling Eye Drops due to lack of assurance of sterility. The recall affects 499,673 cartons distributed nationwide in the U.S.
Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling Rohto Cooling Eye Drops Max Strength because there is a lack of assurance regarding the product's sterility.
The FDA is recalling ROHTO DRY-AID cooling eye drops due to lack of assurance of sterility. The product was distributed nationwide in the United States.
Major Pharmaceuticals is voluntarily recalling Levothyroxine Sodium Tablets (50 mcg) from lot N02200 due to subpotency, meaning the tablets may contain less active ingredient than labeled. Products were distributed nationwide in the USA.
Major Pharmaceuticals is voluntarily recalling certain lots of Levothyroxine Sodium Tablets (75 mcg) because the medication may be subpotent.
Major Pharmaceuticals is recalling LEVOTHYROXINE SODIUM 150 mcg tablets because some batches contain less active ingredient than labeled, potentially reducing thyroid hormone effectiveness.
Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling certain lots of Rohto Cooling Eye Drops because the company cannot assure the sterility of the product.
Fresenius Kabi is recalling 93,250 vials of Xylocaine (lidocaine HCl) injection due to the presence of particulate matter, specifically hair found in the product.
Fresenius Kabi is recalling 92,600 vials of NAROPIN (ropivacaine hydrochloride) injection, 0.5%, 10/2028, due to the presence of particulate matter, including hair, found in the product.
Major Pharmaceuticals is voluntarily recalling Levothyroxine Sodium Tablets (125 mcg) because the medication may be subpotent.
Fresenius Kabi is recalling lidocaine injection vials after hair was found in the product. The recall affects 181,225 vials distributed nationwide.
Ascend Laboratories is recalling 6,192 bottles of Amlodipine and Olmesartan Medoxomil tablets nationwide due to failed dissolution specifications and Olmesartan content below specifications.
Fresenius Kabi is recalling Glycopyrrolate Injection due to the presence of particulate matter, specifically hair found in the product.
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