--- title: "Glenmark Pharmaceuticals Inc., USA Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Glenmark Pharmaceuticals Inc., USA recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/glenmark-pharmaceuticals-inc-usa/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Glenmark Pharmaceuticals Inc., USA recall records **105** reported ongoing 116 records in this archive. Latest source date Jul 23, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jul 23, 2026 FDA drug enforcement ### [Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.](https://isitonrecall.com/recall/fda-drug-d-0731-2026-azelaic-acid-gel-15-50-gram-tubes-for-topical-use-only-rx-only-distributed-by-glenmark-pharmaceutica/) CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received. Class II Reported ongoing Distribution: Nationwide within the United States. [Official source for Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pha...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0731-2026%22) May 27, 2026 FDA drug enforcement ### [Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 day regimen, Rx only...](https://isitonrecall.com/recall/fda-drug-d-0588-2026-alyacen-7-7-7-norethindrone-and-ethinyl-estradiol-tablets-usp-0-5mg-0-035mg-0-75mg-0-035mg-1-mg-0-0/) Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities. Class II Reported ongoing Distribution: USA Nationwide. [Official source for Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0588-2026%22) Dec 30, 2025 FDA drug enforcement ### [Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah...](https://isitonrecall.com/recall/fda-drug-d-0246-2026-ondansetron-orally-disintegrating-tablets-usp-4mg-30-tablets-3-blistercards-each-containing-10-table/) Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale. Class II Reported ongoing Distribution: Nationwide within the United States [Official source for Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 1...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0246-2026%22) Nov 21, 2025 FDA drug enforcement ### [Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-cou...](https://isitonrecall.com/recall/fda-drug-d-0199-2026-bisoprolol-fumarate-and-hydrochlorothiazide-tablets-usp-2-5-mg-6-25-mg-packaged-as-a-30-count-bottle/) Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe Class III Reported ongoing Distribution: Nationwide in the USA [Official source for Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-coun...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0199-2026%22) Nov 18, 2025 FDA drug enforcement ### [Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for Avkare, Pulaski, TN 3...](https://isitonrecall.com/recall/fda-drug-d-0222-2026-nebivolol-tablets-20-mg-90-tablets-rx-only-manufactured-by-glenmark-pharmaceuticals-limited-pithampu/) Cross Contamination with Other Products Class III Reported ongoing Distribution: U.S. Nationwide [Official source for Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited,...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0222-2026%22) Sep 17, 2025 FDA drug enforcement ### [Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark P...](https://isitonrecall.com/recall/fda-drug-d-0662-2025-azelaic-acid-gel-15-50-grams-for-topical-use-only-rx-only-manufactured-by-glenmark-pharmaceuticals-l/) CGMP Deviations: Market complaints received for gritty texture (grainy) Class II Reported ongoing Distribution: Nationwide within the United States [Official source for Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmac...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0662-2025%22) Sep 3, 2025 FDA drug enforcement ### [Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blisters each containing 28 Tablets, Rx only, 28 day Regimen, Ma...](https://isitonrecall.com/recall/fda-drug-d-0021-2026-viorele-desogestrel-and-ethinyl-estradiol-usp-0-15-mg-0-02-mg-and-ethinyl-estradiol-tablets-usp-0-01/) Failed Impurities/Degradation Specifications Class II Reported ongoing Distribution: US Nationwide. [Official source for Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0021-2026%22) Aug 8, 2025 FDA drug enforcement ### [Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India, Manufactured for: G...](https://isitonrecall.com/recall/fda-drug-d-0583-2025-theophylline-extended-release-tablets-400mg-100-count-bottle-rx-only-manufactured-by-glenmark-pharma/) Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution... Class II Reported ongoing Distribution: USA nationwide. [Official source for Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0583-2025%22) Aug 7, 2025 FDA drug enforcement ### [Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162-01; Rx only, Manufactured by: Glenmark Pharmaceuticals L...](https://isitonrecall.com/recall/fda-drug-d-0577-2025-carvedilol-tablets-usp-3-125-mg-packaged-as-a-500-count-bottle-ndc-68462-162-05-b-100-count-bottle-n/) CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-coun...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0577-2025%22) Aug 7, 2025 FDA drug enforcement ### [Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmac...](https://isitonrecall.com/recall/fda-drug-d-0578-2025-carvedilol-tablets-usp-12-5-mg-500-count-bottle-rx-only-manufactured-by-glenmark-pharmaceuticals-ltd/) CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceut...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0578-2025%22) Aug 7, 2025 FDA drug enforcement ### [Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceu...](https://isitonrecall.com/recall/fda-drug-d-0579-2025-carvedilol-tablets-usp-25-mg-500-count-bottle-rx-only-manufactured-by-glenmark-pharmaceuticals-ltd-c/) CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceutic...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0579-2025%22) Aug 6, 2025 FDA drug enforcement ### [Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, M...](https://isitonrecall.com/recall/fda-drug-d-0587-2025-carvedilol-tablets-usp-12-5-mg-500-tablets-per-carton-rx-only-manufactured-by-glenmark-pharmaceutica/) CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm Class II Reported ongoing Distribution: Nationwide within the USA [Official source for Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Phar...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0587-2025%22) Aug 6, 2025 FDA drug enforcement ### [Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Mad...](https://isitonrecall.com/recall/fda-drug-d-0588-2025-carvedilol-tablets-usp-25-mg-500-tablets-per-carton-rx-only-manufactured-by-glenmark-pharmaceuticals/) CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm Class II Reported ongoing Distribution: Nationwide within the USA [Official source for Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharma...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0588-2025%22) May 19, 2025 FDA drug enforcement ### [Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, Indi...](https://isitonrecall.com/recall/fda-drug-d-0462-2025-ezetimibe-and-simvastatin-tablets-10mg-40mg-90-count-bottle-rx-only-manufactured-by-glenmark-pharmac/) Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study. Class III Reported ongoing Distribution: Nationwide USA and PR [Official source for Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0462-2025%22) May 15, 2025 FDA drug enforcement ### [Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa - 403513, Indi...](https://isitonrecall.com/recall/fda-drug-d-0452-2025-theophylline-anhydrous-extended-release-tablets-600-mg-100-tablets-per-bottle-rx-only-manufactured-b/) OOS results reported for the Dissolution (by UV) test. Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manuf...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0452-2025%22) Mar 13, 2025 FDA drug enforcement ### [Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmar...](https://isitonrecall.com/recall/fda-drug-d-0314-2025-fenofibrate-capsules-67-mg-usp-100-count-bottle-rx-only-manufactured-by-glenmark-pharmaceuticals-lim/) CGMP Deviations Class II Reported ongoing Distribution: U.S. Nationwide [Official source for Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuti...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0314-2025%22) Mar 13, 2025 FDA drug enforcement ### [Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, ...](https://isitonrecall.com/recall/fda-drug-d-0315-2025-propafenone-hydrochloride-extended-release-capsules-225mg-60-count-bottle-rx-only-manufactured-by-gl/) CGMP Deviations Class II Reported ongoing Distribution: U.S. Nationwide [Official source for Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, Rx Only, Manufactured...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0315-2025%22) Mar 13, 2025 FDA drug enforcement ### [Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, Rx Only Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, M...](https://isitonrecall.com/recall/fda-drug-d-0316-2025-propafenone-hydrochloride-extended-release-capsules-325mg-60-count-bottle-rx-only-manufactured-by-gl/) CGMP Deviations Class II Reported ongoing Distribution: U.S. Nationwide [Official source for Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, Rx Only Manufactured ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0316-2025%22) Mar 13, 2025 FDA drug enforcement ### [Solifenacin Succinate Tablets 10MG, a. 30-count bottle (NDC# 68462-387-30), b. 90-Count Bottle (NDC 68462-387-90),Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pit...](https://isitonrecall.com/recall/fda-drug-d-0317-2025-solifenacin-succinate-tablets-10mg-a-30-count-bottle-ndc-68462-387-30-b-90-count-bottle-ndc-68462-38/) CGMP Deviations Class II Reported ongoing Distribution: U.S. Nationwide [Official source for Solifenacin Succinate Tablets 10MG, a. 30-count bottle (NDC# 68462-387-30), b. 90-Count Bottle (N...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0317-2025%22) Mar 13, 2025 FDA drug enforcement ### [Voriconazole Tablets 200 mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pha...](https://isitonrecall.com/recall/fda-drug-d-0318-2025-voriconazole-tablets-200-mg-30-count-bottle-rx-only-manufactured-by-glenmark-pharmaceuticals-limited/) CGMP Deviations Class II Reported ongoing Distribution: U.S. Nationwide [Official source for Voriconazole Tablets 200 mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0318-2025%22) ## Reasons in these listed records - CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received. - Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities. - Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale. - Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe These examples come from this result page and are not a ranking of every recall reason. ## Checking Glenmark Pharmaceuticals Inc., USA ### Is there a recall on glenmark pharmaceuticals inc., usa right now? This archive contains 116 records, including 105 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Glenmark Pharmaceuticals Inc., USA](https://isitonrecall.com/check/?q=Glenmark%20Pharmaceuticals%20Inc.%2C%20USA) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)