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.
Preferred Pharmaceuticals is recalling Pravastatin Sodium 20 mg tablets nationwide due to manufacturing practice deviations identified during FDA inspection. No illnesses have been reported.
Azurity Pharmaceuticals is recalling Testosterone Cypionate Injection due to complaints that crystals fail to redissolve after warming and shaking, a manufacturing quality defect affecting specific lots nationwide.
Preferred Pharmaceuticals is recalling Clopidogrel Tablets 75 mg nationwide due to manufacturing quality deviations found at manufacturer Accord Healthcare. The recall affects specific lot codes expiring October 2023.
Direct Rx is recalling Alprazolam 0.5 mg tablets (Lot 11AP2219, expires 4/30/23) nationwide due to potential cross-contamination concerns at the manufacturer. No illnesses have been reported.
RemedyRepack Inc. voluntarily recalled Simvastatin 10 mg tablets nationwide due to manufacturing practice deviations. The recall affects specific lots distributed to consignees throughout the United States.
Preferred Pharmaceuticals is recalling Alprazolam 1mg tablets due to manufacturing deviations that created a potential cross-contamination risk. Affected lots expire August 2024.
Preferred Pharmaceuticals is recalling Montelukast Sodium Tablets, USP, 10 mg due to current Good Manufacturing Practice deviations discovered during an FDA inspection. The product was distributed nationwide.
RemedyRepack Inc. is recalling Rosuvastatin 10mg tablets due to cGMP deviations in the manufacturing process. The recall affects 30-count and 90-count bottles distributed nationwide.
Preferred Pharmaceuticals is recalling Simvastatin 40 mg tablets nationwide due to manufacturing practice violations at the production facility. The recall is precautionary.
Preferred Pharmaceuticals is recalling Simvastatin Tablets, USP, 80 mg due to manufacturing quality control deviations identified at Accord Healthcare during FDA inspection. Approximately 57 bottles distributed nationwide.
Preferred Pharmaceuticals is recalling Alprazolam 0.5mg tablets nationwide due to CGMP manufacturing deviations at Breckenridge Pharmaceuticals that created a potential cross-contamination risk.
Preferred Pharmaceuticals is recalling 264 bottles of Rosuvastatin Tablets 5mg nationwide due to manufacturing deviations discovered during FDA inspection. No illnesses have been reported.
RemedyRepack Inc. is recalling 3,426 bottles of Atorvastatin 20 mg tablets nationwide due to Good Manufacturing Practice (cGMP) deviations. The recall was initiated voluntarily by the manufacturer.
RemedyRepack Inc. is voluntarily recalling Doxazosin 2 mg tablets distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 30-count and 90-count bottles.
Preferred Pharmaceuticals is recalling Simvastatin Tablets, USP, 10 mg due to manufacturing compliance deviations identified at Accord Healthcare. No illnesses or injuries have been reported.
RemedyRepack Inc. voluntarily recalled 132 bottles of Rosuvastatin 5mg tablets nationwide due to current Good Manufacturing Practice deviations. No illnesses or injuries have been reported.
Preferred Pharmaceuticals is recalling Atorvastatin Calcium Tablets 20 mg nationwide due to manufacturing practice deviations at the manufacturer, Accord Healthcare, Inc., identified during FDA inspection.
Preferred Pharmaceuticals is recalling 32 bottles of Tadalafil 20 mg tablets due to manufacturing process deviations identified during FDA inspection. The recalled lots expire January 31, 2024.
Direct Rx is recalling Alprazolam 1 mg tablets nationwide due to potential cross contamination at the manufacturer. No illnesses or injuries have been reported.
RemedyRepack Inc. is recalling Ropinirole 2mg tablets due to manufacturing practice deviations. No illnesses have been reported.
Preferred Pharmaceuticals is recalling Glimepiride Tablets 4 mg due to Current Good Manufacturing Practice (cGMP) deviations identified at the manufacturer, Accord Healthcare. The recall affects 15 bottles distributed nationwide.
RemedyRepack Inc. is recalling Glimepiride 2 mg tablets distributed nationwide due to manufacturing quality deviations (cGMP violations). The recall affects 220 bottles across multiple lot numbers.
RemedyRepack is voluntarily recalling Rosuvastatin 40mg tablets due to manufacturing practice deviations. The recall affects specific lot numbers expiring 07/31/2025 distributed nationwide.
Preferred Pharmaceuticals is recalling Simvastatin Tablets, USP, 20 mg, in three package sizes due to manufacturing process deviations at Accord Healthcare. The affected tablets were distributed nationwide.
RemedyRepack Inc. is recalling Aripiprazole 5mg tablets (lot J0620431-052322) due to cGMP deviations affecting manufacturing practices. The voluntary recall includes 3 bottles distributed nationwide.
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