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.
Viatris Inc. is recalling Levothyroxine Sodium 200 mcg tablets nationwide due to potency failures—some tablets are superpotent while others are subpotent. Affected lots expire July 2025; patients should contact their healthcare provider.
Mckesson Medical-Surgical Inc. is recalling HYLENEX RECOMBINANT (hyaluronidase) injection due to cGMP deviations involving a temperature excursion during storage, which may have compromised drug potency.
Dr. Reddy's Laboratories is recalling 7,233 bottles of JAVYGTOR (sapropterin dihydrochloride) tablets nationwide because the medication failed specifications for impurities and degradation products. Affected patients should contact their healthcare provider.
LNK International recalls Kirkland Severe Cold & Flu Plus Congestion due to Current Good Manufacturing Practice (CGMP) deviations. The product should not have been released and was distributed to wholesale customers.
VitalityXtra Capsules containing undeclared sildenafil and diclofenac are being recalled nationwide. The product was marketed without required FDA approval and poses health risks from undeclared pharmaceutical ingredients.
ZoomMax Capsules have been recalled by the FDA due to containing undeclared sildenafil and diclofenac. The product was marketed without FDA approval.
PeakMax Capsules contain undeclared sildenafil and diclofenac and were marketed without FDA approval. This Class I recall affects capsules distributed nationwide.
ZapMax Capsules, 500 mg are recalled for containing undeclared sildenafil and diclofenac without FDA approval. The product was distributed nationwide; consumers should stop using immediately and consult their healthcare provider.
AvKARE is recalling Cinacalcet Tablets 30 mg due to nitrosamine impurity levels exceeding safe limits. Affected bottles nationwide should not be used.
Aurobindo Pharma USA is recalling Cinacalcet 30mg tablets nationwide due to N-nitroso Cinacalcet impurity above FDA limits. Patients should contact their healthcare provider about their medication.
Armonia Natural Store LLC is recalling OneMultivitaminic GAF-PLUS Advance 300ml for containing undeclared Acetaminophen, Dexamethasone Phosphate, and Aspartame. Consumers should discontinue use immediately.
Glenmark Pharmaceuticals is recalling 4,704 bottles of Diltiazem Hydrochloride extended-release capsules 90mg due to manufacturing contamination with an impurity above FDA limits. Two lot numbers distributed nationwide are affected.
Amerisource Health Services LLC recalls Duloxetine 20 mg delayed-release capsules due to the presence of N-nitroso-duloxetine impurity above acceptable limits. The affected bottles were distributed in Pennsylvania, Ohio, and Puerto Rico.
AvKARE is recalling 2,396 bottles of Cinacalcet Tablets 60 mg (Lot #44550) distributed nationwide due to CGMP deviations. The tablets contain N-Nitroso-Cinacalcet, a nitrosamine impurity, above acceptable intake limits.
Amerisource Health Services is recalling specific lots of Duloxetine 30 mg capsules due to N-nitroso-duloxetine impurity levels exceeding FDA recommendations. Patients taking affected lots should contact their healthcare provider immediately.
Rising Pharma is recalling 122,925 bottles of Duloxetine 30 mg capsules nationwide due to a manufacturing deviation: the presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Midlab Incorporated is recalling ROYALAB Germ Away Antibacterial Hand Soap (1-gallon, Lot 0711241) due to out-of-specification microbiological test results. The product failed manufacturing quality standards.
American Regent, Inc. is recalling specific lots of Venofer (iron sucrose) injection due to potential glass delamination in vials. The intravenous drug distributed nationwide may contain particulate matter.
Lannett Company is recalling 1,608 bottles of Lisdexamfetamine Dimesylate 10 mg capsules nationwide due to failed content uniformity. The active ingredient may be unevenly distributed in some capsules.
Glenmark Pharmaceuticals recalls Diltiazem Hydrochloride extended-release capsules due to presence of N-nitroso-desmethyl-diltiazem impurity above FDA recommended limits. The recall affects 12,864 bottles distributed nationwide.
Midlab Incorporated is recalling Array Liquid Antiseptic Handwash due to manufacturing quality deviations. The product failed microbiological testing and may not provide adequate antimicrobial protection.
Glenmark Pharmaceuticals is recalling Diltiazem Hydrochloride capsules because they contain a chemical impurity above safe limits. About 7,296 bottles were distributed nationwide.
AvKARE is recalling Sunitinib Malate 25 mg capsules nationwide due to a label mix-up in lot 100049501. The FDA has classified this as a Class II recall.
Midlab Incorporated is recalling Genuine Joe Antibacterial Lotion Soap (Lot 0711241) nationwide due to out-of-specification microbial test results found during manufacturing quality checks.
Aurobindo Pharma USA Inc is recalling Cinacalcet 60mg tablets nationwide due to N-nitroso Cinacalcet impurity exceeding FDA recommended interim limits.
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