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.
Glenmark Pharmaceuticals Inc., USA is recalling Naproxen Sodium Tablets, USP 550mg nationwide due to CGMP (Current Good Manufacturing Practice) deviations identified during manufacturing. The recall affects lot #17231956 with expiration date Aug-25.
Glenmark Pharmaceuticals Inc., USA is recalling specific lots of Pravastatin Sodium Tablets 80mg due to Current Good Manufacturing Practice (CGMP) deviations. The recall applies to affected lots distributed nationwide and was initiated voluntarily by the firm.
Glenmark Pharmaceuticals Inc. is voluntarily recalling Gabapentin 600mg tablets (500-count bottles) nationwide due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing.
Glenmark Pharmaceuticals is voluntarily recalling Saxagliptin 5mg tablets nationwide due to CGMP deviations. Affected lot numbers are 17232460 and 17241194.
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Lacosamide Tablets 50mg due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects specific lots distributed nationwide.
Glenmark Pharmaceuticals is recalling Rufinamide 200mg tablets nationwide due to manufacturing process deviations. The voluntary recall affects certain lot numbers with July 2025 expiration dates.
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Fluphenazine Hydrochloride Tablets 2.5mg nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The affected lot is 17232214 with expiration date September 2025.
Glenmark Pharmaceuticals is voluntarily recalling Pravastatin Sodium 80mg tablets due to Current Good Manufacturing Practice deviations. The nationwide recall affects specific lot numbers and remains ongoing.
Glenmark Pharmaceuticals is recalling solifenacin succinate 10mg tablets nationwide due to manufacturing process deviations. The voluntary recall affects specific lot numbers distributed across the United States.
Glenmark Pharmaceuticals is recalling Lacosamide Tablets 200mg nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall is voluntary and affects specific lot numbers with expiration dates ranging from April 2025 to April 2026.
Glenmark Pharmaceuticals Inc., USA is recalling Propafenone Hydrochloride Extended-Release Capsules 225mg due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects lot #17230819 with expiration date March 2025, distributed nationwide.
Glenmark Pharmaceuticals is voluntarily recalling Voriconazole tablets nationwide due to manufacturing process deviations. No illnesses or injuries have been reported.
B. Braun Medical Inc. is recalling a sodium chloride irrigation solution due to the presence of particulate matter. The product was distributed to 12 distributors who may have further distributed it nationwide.
Glenmark Pharmaceuticals Inc., USA is recalling Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall is voluntary and initiated by the firm.
Glenmark Pharmaceuticals is voluntarily recalling Prochlorperazine Maleate 10mg tablets (NDC# 68462-890-01) distributed nationwide due to manufacturing process deviations. No illnesses or injuries have been reported.
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Pravastatin Sodium Tablets, USP, 20mg, 90-count bottles (Lot # 17230810, expiration Mar-26) nationwide due to manufacturing process deviations.
Glenmark Pharmaceuticals Inc. is recalling Colesevelam Hydrochloride 625mg tablets nationwide due to CGMP deviations. The firm initiated this Class II voluntary recall; no illnesses or injuries have been reported.
Glenmark Pharmaceuticals Inc., USA is recalling Nitroglycerin Sublingual Tablets 0.4 MG due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects specific lot numbers distributed nationwide.
Glenmark Pharmaceuticals Inc. USA is recalling Voriconazole Tablets 50mg (Lot # 17231045, exp. date Apr-25) distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing.
Glenmark Pharmaceuticals Inc. USA is recalling Clindamycin Hydrochloride Capsules, USP 300mg due to CGMP deviations. The product has been distributed nationwide.
Glenmark Pharmaceuticals Inc., USA is recalling Metformin Hydrochloride Extended-Release Tablets 1000mg due to manufacturing practice deviations. The recall affects 90-count bottles distributed nationwide and is voluntary.
Glenmark Pharmaceuticals Inc. is recalling specific lots of Nitroglycerin 0.3MG sublingual tablets distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations. Patients should consult their healthcare provider.
Asegua Therapeutics is recalling 18,541 cartons of Sofosbuvir and Velpatasvir tablets nationwide due to defective blister packs that are not properly sealed, resulting in loose tablets in cartons. No illnesses or injuries have been reported.
Glenmark Pharmaceuticals is recalling Ranolazine Extended-Release 1000mg tablets (Lot 17240040) nationwide due to manufacturing deviations. This is a voluntary, firm-initiated recall.
Glenmark Pharmaceuticals is recalling Saxagliptin 2.5mg tablets nationwide due to manufacturing quality issues. The firm initiated this voluntary recall on March 13, 2025.
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