Glenmark Pharmaceuticals Inc., USA

Complete recall history across all FDA and CPSC categories — 139 total recalls

Glenmark Pharmaceuticals Inc., USA appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (139)

FDA drug safety enforcement actions by Glenmark Pharmaceuticals Inc., USA. Showing most recent 50.

Date Product Reason Class
Dec 30, 2025 Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercar... Defective container: Preferred Pharmaceuticals received a letter from the man... Class II
Nov 21, 2025 Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, pac... Cross Contamination with Other Products: Testing of reserve samples showed pr... Class III
Nov 18, 2025 Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Phar... Cross Contamination with Other Products Class III
Sep 17, 2025 Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured ... CGMP Deviations: Market complaints received for gritty texture (grainy) Class II
Sep 3, 2025 Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl... Failed Impurities/Degradation Specifications Class II
Aug 8, 2025 Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manuf... Failed Dissolution Specifications: Failure results (above) were reported for ... Class II
Aug 7, 2025 Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: G... CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity... Class II
Aug 7, 2025 Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462... CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity... Class II
Aug 7, 2025 Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by:... CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity... Class II
Aug 6, 2025 Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactur... CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity ... Class II
Aug 6, 2025 Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured... CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity ... Class II
May 19, 2025 Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manuf... Failed Impurities/Degradation Specifications: Out of Specification (OOS) for ... Class III
May 15, 2025 Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bo... OOS results reported for the Dissolution (by UV) test. Class II
Mar 13, 2025 Fluphenazine Hydrochloride Tablets 2.5mg, 100-count bottle, Rx Only, Manufact... CGMP Deviations Class II
Mar 13, 2025 Teriflunomide Tablets, 14mg, 30-count bottle, Rx Only, Manufactured by: Glenm... CGMP Deviations Class II
Mar 13, 2025 Solifenacin Succinate Tablets 10MG, a. 30-count bottle (NDC# 68462-387-30), ... CGMP Deviations Class II
Mar 13, 2025 Voriconazole Tablets 200 mg, 30-count bottle, Rx Only, Manufactured by: Glenm... CGMP Deviations Class II
Mar 13, 2025 Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, R... CGMP Deviations Class II
Mar 13, 2025 Lacosamide Tablets, 50mg, 60-count bottles, Rx Only, Manufactured by: Glenmar... CGMP Deviations Class II
Mar 13, 2025 Nitroglycerin Sublingual Tablets 0.3MG, 100-count bottles, Manufactured by: G... CGMP Deviations Class II
Mar 13, 2025 Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles, Manufactur... CGMP Deviations Class II
Mar 13, 2025 Indomethacin Extended-Release Capsules, 75mg, 60-count bottles, Manufactured ... CGMP Deviations Class II
Mar 13, 2025 Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmar... CGMP Deviations Class II
Mar 13, 2025 Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottl... CGMP Deviations Class II
Mar 13, 2025 Fluphenazine Hydrochloride Tablets, 10mg, 100-Count Bottle, Rx Only, Manufact... CGMP Deviations Class II
Mar 13, 2025 Lacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark... CGMP Deviations Class II
Mar 13, 2025 Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottl... CGMP Deviations Class II
Mar 13, 2025 Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: G... CGMP Deviations Class II
Mar 13, 2025 Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmar... CGMP Deviations Class II
Mar 13, 2025 Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottl... CGMP Deviations Class II
Mar 13, 2025 Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: ... CGMP Deviations Class II
Mar 13, 2025 Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: ... CGMP Deviations Class II
Mar 13, 2025 Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenma... CGMP Deviations Class II
Mar 13, 2025 Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count pack... CGMP Deviations Class II
Mar 13, 2025 Nitroglycerin Sublingual Tablets 0.4MG 100-count carton, Rx Only, Manufactur... CGMP Deviations Class II
Mar 13, 2025 Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count... CGMP Deviations Class II
Mar 13, 2025 Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactu... CGMP Deviations Class II
Mar 13, 2025 Voriconazole Tablets 50mg, 30-count bottle, Rx Only, Manufactured by: Glenmar... CGMP Deviations Class II
Mar 13, 2025 Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, R... CGMP Deviations Class II
Mar 13, 2025 Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark... CGMP Deviations Class II
Mar 13, 2025 Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).... CGMP Deviations Class II
Mar 13, 2025 Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactu... CGMP Deviations Class II
Mar 13, 2025 Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenma... CGMP Deviations Class II
Mar 13, 2025 Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.... CGMP Deviations Class II
Mar 13, 2025 Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Man... CGMP Deviations Class II
Mar 13, 2025 Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b)... CGMP Deviations Class II
Mar 13, 2025 Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured... CGMP Deviations Class II
Mar 13, 2025 Frovatriptan Succinate Tablets 2.5mg, 9-count bottle, Rx Only, Manufactured b... CGMP Deviations Class II
Mar 13, 2025 Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: ... CGMP Deviations Class II
Mar 13, 2025 Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b).... CGMP Deviations Class II

View all 139 drug recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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