FDA (Drugs) recall action 96474
The FDA (Drugs) publishes a recall like this one as 39 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 39 pages.
CGMP Deviations
The agency’s own wording, quoted from the enforcement report.
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 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 Inc., USA is voluntarily recalling Carvedilol Tablets, USP 12.5 mg due to CGMP (Current Good Manufacturing Practice) deviations. The recall affects specific lots distributed 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 Inc. is recalling Pravastatin Sodium 20mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects specific lot numbers distributed across the U.S.
Glenmark Pharmaceuticals Inc. is recalling Propafenone Hydrochloride Extended-Release Capsules 325mg (Lot #17230767, expiring Mar-25) distributed nationwide due to current Good Manufacturing Practice (CGMP) deviations. Patients taking this medication should consult their physician before discontinuing use.
Glenmark Pharmaceuticals is voluntarily recalling Propafenone Hydrochloride Extended-Release Capsules 325mg (Lot #17230767, exp. Mar-25) distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations.
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 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. 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. 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.
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 is recalling Propafenone Hydrochloride Extended-Release Capsules 225mg (Lot #17230819) nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall is voluntary and initiated by the manufacturer.
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 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 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 is voluntarily recalling Indomethacin Extended-Release Capsules (75mg) distributed nationwide due to Good Manufacturing Practice deviations identified during FDA oversight.
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Fenofibrate Capsules 67 mg due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 100-count bottles distributed nationwide.
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 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 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 voluntarily recalling Cetirizine HCL 10mg tablets distributed nationwide. The recall was initiated due to Current Good Manufacturing Practice deviations.
Glenmark Pharmaceuticals Inc. USA is recalling Clindamycin Hydrochloride Capsules, USP 300mg due to CGMP deviations. The product has been distributed nationwide.
Glenmark Pharmaceuticals is voluntarily recalling Rosuvastatin Calcium 40mg tablets nationwide due to manufacturing practice deviations. The recall affects specific lot numbers expiring February through June 2026.
Glenmark Pharmaceuticals Inc. is voluntarily recalling Teriflunomide 14mg tablets (Lot #17232462, expiring Nov-25) distributed nationwide due to current good manufacturing practice (CGMP) deviations discovered during production.