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.
Dr. Reddy's Laboratories is recalling 8,280 bottles of Tacrolimus 1 mg capsules after a 0.5 mg capsule was found in a bottle. The wrong-strength capsule could cause dosage confusion.
Fresenius Medical Care is recalling 69,590 bags of DELFLEX Peritoneal Dialysis Solution due to lack of sterility assurance. The affected lot was distributed nationwide.
Seaway Pharma Inc. recalled Premier Value Tussin Cough DM due to possible microbial contamination in manufacturing water. No contamination was found in finished products and no illnesses have been reported.
Azurity Pharmaceuticals recalls Eprontia (topiramate) oral solution nationwide because routine stability testing found an out-of-specification impurity. The chemical defect raised concerns about the drug's purity and patient safety.
Quality Choice No Drip nasal decongestant is being recalled due to a manufacturing deviation in water purification. No contamination was detected in the finished products.
Seaway Pharma is recalling oxymetazoline nasal spray due to manufacturing process deviations. No contamination was found in the final products.
Quality Choice No Drip Nasal Decongestant is being recalled because purified water used in manufacturing may have contained microbial contamination. No contamination was detected in the final products.
Magnum XXL 9800 capsules contain undeclared sildenafil and were marketed without FDA approval. The product was distributed nationwide via Amazon.
Brut Classic Antiperspirant & Deodorant in 4 oz and 6 oz aerosol cans is being recalled due to benzene contamination. The recall affects all lots distributed in the United States and Canada.
Sure Regular Antiperspirant Deodorant Aerosol (6 oz cans) sold nationwide in the US and Canada is being recalled due to benzene contamination. All lots expiring on or before August 2023 are affected.
Sure Unscented Deodorant Aerosol is being recalled nationwide due to benzene contamination. Consumers should stop using affected cans and contact the manufacturer.
Cardinal Healthcare is recalling low-dose aspirin tablets nationwide due to a CGMP deviation involving improper storage temperatures. Products may have been exposed to conditions outside the manufacturer's labeled storage requirements, potentially affecting product stability.
Sandoz Inc is recalling Enoxaparin Sodium Injection (batch SAH06821A) nationwide due to CGMP deviations: products were exposed to temperatures outside labeled storage conditions, potentially affecting drug stability.
Cardinal Healthcare is recalling an ipratropium bromide and albuterol sulfate inhalation solution nationwide after the product was exposed to temperatures outside labeled storage conditions. The deviation may affect drug potency.
Cardinal Healthcare is recalling Amoxicillin 875mg tablets due to CGMP deviations where products were exposed to temperatures outside their labeled storage conditions, affecting nationwide distribution.
Cardinal Healthcare recalls Warfarin Sodium tablets distributed nationwide due to products being exposed to improper storage temperatures.
Bumetanide tablets manufactured by Amneal Pharmaceuticals are being recalled because they were exposed to temperatures outside their labeled storage conditions. The recall affects batch AM211171 distributed nationwide.
Cardinal Healthcare recalls Warfarin Sodium Tablets (5 mg) nationwide due to CGMP deviations: products were exposed to temperatures outside labeled storage conditions, potentially affecting drug stability.
Cardinal Healthcare is recalling Estradiol 0.5mg tablets (Batch 100023687) nationwide due to exposure to temperatures outside labeled storage specifications. Temperature exposure may affect medication stability.
Cardinal Healthcare recalls batch 62002532 of Wixela Inhub inhalation powder nationwide due to CGMP deviations. Products were exposed to temperatures outside labeled storage conditions, potentially affecting product stability.
A prescription lansoprazole suspension has been recalled because batches were exposed to temperatures outside the manufacturer's labeled storage range. This manufacturing quality issue affects Batch 21025A nationwide.
Cardinal Healthcare is recalling Hydralazine Hydrochloride tablets nationwide because products were exposed to temperatures outside labeled storage conditions due to manufacturing practice deviations.
Cardinal Healthcare is recalling Donepezil Hydrochloride 5 mg tablets (Batch 17605) distributed nationwide because they were exposed to temperatures outside labeled storage conditions, which could affect drug stability.
Donepezil Hydrochloride 10mg tablets are recalled due to exposure to temperatures outside labeled storage conditions. The FDA classified this Class II recall due to potential effects on drug stability.
AnazaoHealth is recalling B-Complex injection vials due to particulate matter contamination. Affected patients should discontinue use and consult their healthcare provider.
Looking for a different category? Browse all recalls.