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.
Buprenorphine HCl injection is being recalled nationwide due to white crystalline agglomeration found in stored product samples during routine inspection.
Taro Pharmaceuticals recalls 11,196 bottles of Hydrocortisone and Acetic Acid Otic Solution nationwide due to failed quality specifications including out-of-spec impurities and lower-than-established assay levels discovered during stability testing.
Glenmark Pharmaceuticals is recalling 16,944 bottles of Ranolazine 500mg tablets nationwide due to failed dissolution specifications. Tablets may not dissolve properly, potentially affecting drug efficacy.
OXAYDO oxycodone 7.5 mg tablets distributed nationwide are being recalled because they contain lower potency than labeled. The affected lot is 22W02 with expiration 01/31/2025.
Medline Industries is recalling REMEDY Antifungal powder nationwide because it contains insufficient miconazole nitrate (the active ingredient). The product was shipped before assay testing was complete.
Zydus Pharmaceuticals is recalling Oxybutynin Extended-Release Tablets (15 mg) after dissolution testing showed out-of-specification results at the 6-month mark. No illnesses have been reported.
Zydus Pharmaceuticals is recalling specific lots of oxybutynin chloride extended-release 10 mg tablets nationwide due to out-of-specification dissolution test results at the 6-month stability timepoint. The affected tablets may not release medication properly.
V-Force Homeopathic bottles contain pig-derived adrenal gland instead of the labeled cow-derived ingredient. About 1,333 bottles with lot Z65842 distributed to Florida and potentially other states.
VistaPharm is recalling Mycophenolate Mofetil Oral Suspension because the adaptor does not fit the bottle after reconstitution. Affected lots were distributed nationwide and to Saudi Arabia.
Sun Pharmaceutical is recalling 7,392 bottles of Liothyronine Sodium Tablets (Lot DND0058A) nationwide due to failed impurity and degradation specifications. Patients should contact their healthcare provider.
GlaxoSmithKline is recalling TUMS Antacid tablets (Lot HA7G, expiration 8/31/2027) due to contamination with glass mineral wool. The product was distributed nationwide.
Padagis US LLC is recalling Gynazole 1 butoconazole nitrate vaginal cream nationwide due to a manufacturing error where hydrophilic colloidal silica was used instead of hydrophobic colloidal silica.
GlaxoSmithKline is recalling TUMS Antacid tablets (Lot HB2G) due to glass mineral wool contamination. Affected product was distributed nationwide.
GlaxoSmithKline is recalling TUMS antacid tablets in Lot KH5L due to glass mineral wool contamination. Affected consumers should stop use immediately.
GlaxoSmithKline recalls TUMS Antacid 1000 mg Assorted Berries chewable tablets (lot HR6A) due to presence of glass mineral wool. The product was distributed nationwide.
GlaxoSmithKline is recalling TUMS Antacid (1000mg Calcium Carbonate) due to the presence of glass mineral wool. The affected lot (HV6B) was distributed nationwide.
GlaxoSmithKline is recalling TUMS Antacid 1000 mg chewable tablets in Assorted Berries flavor due to glass mineral wool contamination found in some bottles. Product was distributed nationwide.
Sun Pharmaceutical is recalling approximately 2,304 bottles of Liothyronine Sodium Tablets, USP, 25 mcg (lot DNC2204A) due to failed impurity and degradation specifications. The affected medication was distributed nationwide.
TUMS Antacid chewable tablets (Assorted Berries, 1000 mg, lot HR5W) are being recalled nationwide because some bottles contain glass mineral wool. Consumers should stop using affected bottles immediately.
Safecor Health recalls Strong Iodine Solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The prescription product was distributed in multiple lots across the U.S.
Glenmark Pharmaceuticals is recalling Bisoprolol Fumarate and Hydrochlorothiazide Tablets due to failed impurities and degradation specifications. The recall affects 480 bottles distributed nationwide.
Edenbridge Pharmaceuticals recalled opium tincture nationwide because the morphine concentration fell below labeled potency. The voluntary recall affected 4,548 bottles.
The FDA has recalled ION Sinus Spray due to microbial contamination of the non-sterile product. All lots are affected regardless of expiration date.
Biomic Sciences is recalling all lots of ION Sinus Support Nasal Spray due to microbial contamination. The product has been distributed nationwide and internationally.
Biomic Sciences is recalling Restore Sinus Spray due to microbial contamination of the non-sterile product. The product is distributed nationwide and internationally.
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