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.
Zydus Pharmaceuticals is recalling Esomeprazole Magnesium delayed-release oral suspension, 20 mg, due to out-of-specification test results for unknown degradation products detected during long-term stability testing.
KVK Tech, Inc. is recalling 9,680 bottles of Phentermine Hydrochloride Capsules 30mg nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall is voluntary and firm-initiated.
Kenil Healthcare is recalling 9,984 tubes of Artridon topical analgesic (menthol and methyl salicylate) due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects units distributed in Delaware and North Carolina.
Maximum Security Anticavity Gel Toothpaste is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 391,680 tubes distributed in Delaware and North Carolina.
Kenil Healthcare is recalling 10,000 tubes of Rapidol Maximum Strength Hydrocortisone 1% Anti-Itch Cream (2 oz, Lot SP26A, Expiration 09/30/2026) distributed in Delaware and North Carolina due to manufacturing quality issues.
Maximum Security Anticavity Gel Toothpaste (Sodium Fluoride 0.22%, Fresh Mint) distributed in Delaware and North Carolina is being recalled due to CGMP deviations identified by the manufacturer.
KENIL HEALTHCARE PRIVATE LIMITED is recalling KOFAL Original Penetrating Pain Relieving Ointment (methyl salicylate 12%) due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 16,248 jars distributed in Delaware and North Carolina.
Maximum Security Anticavity Gel Toothpaste is being recalled due to Current Good Manufacturing Practice (CGMP) deviations identified by the manufacturer. The recall affects toothpaste tubes distributed in Delaware and North Carolina.
Optim V Anti-Itch Cream (Benzocaine 20% & Resorcinol 3%) is being recalled because the manufacturer did not follow current good manufacturing practice (CGMP) standards. The voluntary recall affects 6,372 tubes distributed in Delaware and North Carolina.
Pharmadel LLC is recalling CURA HONGOS 1% Clotrimazole topical lotion due to Current Good Manufacturing Practice (CGMP) deviations identified during production. The voluntary recall affects approximately 10,128 bottles distributed in Delaware and North Carolina.
KVK Tech, Inc. is recalling Indomethacin Extended-Release Capsules USP, 75 mg (Lot #18400A) nationwide due to cGMP deviations. The recall affects approximately 9,107 bottles distributed nationwide.
Rapidol Triple Antibiotic First Aid Ointment (Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate) distributed in Delaware and North Carolina is being recalled for CGMP deviations. The manufacturer initiated a voluntary recall of 9,336 tubes.
KENIL HEALTHCARE PRIVATE LIMITED is recalling Maximum Security Anticavity Gel Toothpaste sachets distributed in Delaware and North Carolina due to Current Good Manufacturing Practice (CGMP) deviations identified by the FDA.
KENIL HEALTHCARE PRIVATE LIMITED is recalling Nature Mint Anticavity Fluoride Toothpaste due to manufacturing deviations. The recall affects 150,768 tubes distributed in Delaware and North Carolina.
Nature Mint Anticavity Fluoride Toothpaste (0.76% sodium monofluorophosphate, 2.75 OZ tube) is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The affected lots were distributed in Delaware and North Carolina.
KENIL HEALTHCARE PRIVATE LIMITED is voluntarily recalling Nature Mint Anticavity Fluoride Toothpaste due to Current Good Manufacturing Practice (CGMP) deviations. The affected toothpaste was distributed in Delaware and North Carolina.
Empower Pharmacy is recalling Testosterone Cypionate Injection 200 mg/mL (Lot 202364, 8,230 vials) distributed nationwide because the manufacturer cannot assure the product's sterility. Consumers should stop using the product and consult their healthcare provider.
L'Oreal USA is recalling La Roche-Posay Effaclar 3-Step Acne Routine Kits nationwide due to trace levels of benzene detected in one lot. As a precaution, all Effaclar Duo Dual Action Acne Treatment lots are included in the recall.
La Roche-Posay Effaclar Duo acne treatment is being recalled due to detected trace levels of benzene. The recall affects 2,226,801 units distributed nationwide.
L'Oreal USA is voluntarily recalling all lots of La Roche-Posay Effaclar Duo Dual Action Acne Treatment due to detected trace levels of benzene in a specific lot.
BRS Analytical Services is recalling Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% eye lubricant nationwide due to cGMP deviations and lack of assurance of sterility. The recalled product was distributed in 0.5 FL OZ dropper bottles across multiple lots with various expiration dates in 2025 and 2026.
BRS Analytical Services is recalling Lubricant Eye Drops Solution (Polyethylene Glycol 400 and Propylene Glycol) due to manufacturing deviations and lack of assurance of sterility. The product was distributed nationwide.
BRS Analytical Services is recalling Artificial Tears ophthalmic solution (0.5 FL OZ dropper bottles) nationwide due to manufacturing deviations and lack of assured sterility. Affected lots are Lot 126–129, 162–170, and 193–199.
Amneal Pharmaceuticals is recalling Ropivacaine Hydrochloride Injection 0.5% due to the presence of particulate matter. The recall affects specific lots distributed nationwide.
BSO LLC is recalling compounded testosterone pellets nationwide because glass particles were found in vials. Affected lot numbers are 20250207@1 and 20250228@1 (expiration 1/31/2026).
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