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.
Astral SteriTech is recalling 243,825 vials of Ceftriaxone for Injection due to inability to assure sterility. The medication was distributed nationwide and poses a contamination risk.
Apollo Care LLC is recalling VANComycin 1.5g IV injections because the manufacturer could not provide adequate assurance that batches met sterility standards. The recall affects 646 bags distributed in Missouri.
RemedyRepack Inc. is recalling Pyrazinamide 500 mg tablets because the original manufacturer discontinued the quality assurance program that would ensure the product meets identity, strength, quality, and purity standards.
Acme United is recalling PhysiciansCare Allergy, Allergy Plus, and Cold and Cough tablets sold on Amazon.com from January 2021 through August 2022 because the packaging is not child resistant, risking poisoning if young children swallow the contents.
Camber Pharmaceuticals is recalling Atovaquone Oral Suspension due to contamination by Bacillus cereus bacteria. The contamination was discovered during testing of repackaged medication.
The Harvard Drug Group recalled 3,984 cartons of Gabapentin 600 mg tablets distributed nationwide due to a product mixup where one foreign tablet was found.
Apotex Corp. recalls Calcitonin Salmon nasal spray (82,375 bottles) nationwide due to a glass splinter entrapped in the pump mechanism. The defect renders the nasal spray inoperable.
DYNAMITE SUPER capsule is being recalled nationwide because it was marketed without FDA approval and contains undeclared sildenafil and tadalafil, active ingredients used in sexual enhancement products.
The FDA recalls NUX Male Enhancement capsules distributed nationwide because they contain undeclared sildenafil and tadalafil, making them an unapproved drug. Consumers should not use this product.
Pro Power Knight Plus capsules contain undeclared sildenafil and tadalafil, prescription ingredients not listed on the label. The product was marketed as an unapproved drug and poses safety risks.
Family Dollar Stores is recalling Advil Ibuprofen 200mg caplets stored outside temperature requirements. The recall affects units distributed nationwide from July 2022 through March 2023.
Seatex Alcohol Antiseptic 80% (1-gallon containers) is being recalled because the formula does not meet specifications, with superpotency and impurities present. The recall affects lot 220888 distributed in Florida, Georgia, and Texas.
Family Dollar Stores is recalling Advil Liqui-Gels 200 mg ibuprofen capsules (SKUs 0999841 and 0916071) distributed nationwide due to storage outside labeled temperature requirements.
Weleda Inc is recalling Hepatodoron® tablets due to potential metal contamination. The affected batch (J033, expiring January 31, 2027) was distributed nationwide.
PD-Rx Pharmaceuticals is voluntarily recalling 520 bottles of Simvastatin USP 20 mg nationwide due to manufacturing process quality control deviations. No adverse events have been reported.
PD-Rx Pharmaceuticals has recalled 352 bottles of Montelukast Sodium USP 10 mg tablets distributed nationwide due to manufacturing process deviations. This was a voluntary recall by the firm.
PD-Rx Pharmaceuticals is recalling Simvastatin USP 10 mg tablets due to manufacturing quality deviations. The recall affects 37 bottles distributed nationwide.
PD-Rx Pharmaceuticals is recalling 186 bottles of Glimepiride USP 4 mg due to manufacturing deviations. Patients using this medication should contact their healthcare provider to verify if their supply is affected.
Bryant Ranch Prepack is recalling Lidocaine Patch 5% nationwide due to a typographical error on product labels. The labels incorrectly state 'tablet' instead of 'patch', creating potential confusion about the dosage form.
Family Dollar Stores is recalling Advil Dual Action pain reliever tablets (36-caplet bottles, SKU 0902867) nationwide because the product was stored outside labeled temperature requirements.
PD-Rx Pharmaceuticals voluntarily recalled Simvastatin 40 mg due to manufacturing quality issues. The recall affects 393 bottles distributed nationwide, with affected lot expiration dates ranging from May 2023 to April 2024.
Family Dollar Stores is recalling Advil Ibuprofen 200 mg tablets due to a storage temperature deviation during manufacturing and distribution. No illnesses have been reported.
Northwind Pharmaceuticals is recalling 33 bottles of Doxazosin 4mg tablets due to manufacturing quality control deviations. No illnesses or injuries have been reported.
Baxter Healthcare Corporation is recalling 9,788 bags of Dianeal Low Calcium with Dextrose peritoneal dialysis solution due to potential leaks in the Luer component. The recall affects Lot Y405201 distributed nationwide in the United States.
Sun Pharmaceutical is recalling 24,194 prefilled syringes of Fyremadel (ganirelix acetate) injection due to glass contamination found in a unit from lot HAD1190A. The recall affects units distributed nationwide with expiration 02/2024.
Looking for a different category? Browse all recalls.