Glenmark Pharmaceuticals Inc., USA recalls

Glenmark Pharmaceuticals Inc., USA has 141 recalls on record with the FDA and USDA, the earliest in 2018 and the latest reported on 5 Aug 2026. 111 are still ongoing. 7 were reported in the last 12 months. The most frequent reason is manufacturing (cgmp) deviations.

Total recalls141since 2018

Last 12 months7reported

Class I21% of total

Ongoing111latest 5 Aug 2026

Recalls per month, last 24 months

click a bar for that month

3Oct '24 0 6 2Jan '25 16 0 40Apr 0 6 0Jul 6 0 2Oct 0 2 1Jan '26 0 0 0Apr 0 1 0Jul 1 0

Severity split

Class I 2 1%Class II 124 88%Class III 15 11%

Why glenmark pharmaceuticals inc., usa is recalled

Product types

Brands

By year

202632%
20257452%
20242316%
202375%
202296%
202186%
202064%
201986%
201832%

Ongoing glenmark pharmaceuticals inc., usa recalls

111 active

Reported	Class	Recall	Company	Reason	Where
5 Aug 2026Drug	CLASS II	Azelaic Acid Gel, 15% tubes, For Topical Use only recalledAzelaic Acid	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
24 Jun 2026Drug	CLASS II	Alyacen 7/7/7, Norethindrone recalled by Glenmark PharmaceuticalsAlyacen 1/35	Glenmark Pharmaceuticals Inc., USA	Potency & Assay	Nationwide
7 Jan 2026Drug	CLASS II	Ondansetron Orally Disintegrating Tablets, USP, 4mg recalledOndansetron	Glenmark Pharmaceuticals Inc., USA	Packaging Defects	Nationwide
17 Dec 2025Drug	CLASS III	Nebivolol Tablets, 20 mg recalled by Glenmark PharmaceuticalsNebivolol	Glenmark Pharmaceuticals Inc., USA	Other	Nationwide
10 Dec 2025Drug	CLASS III	Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalledBisoprolol Fumarate And Hydrochlorothiazide	Glenmark Pharmaceuticals Inc., USA	Packaging Defects	Nationwide
22 Oct 2025Drug	CLASS II	Viorele, Desogestrel and Ethinyl Estradiol recalledViorele	Glenmark Pharmaceuticals Inc., USA	Potency & Assay	Nationwide

All glenmark pharmaceuticals inc., usa recalls, newest first

141 total

Reported	Class	Recall	Company	Reason	Where
5 Aug 2026Drug	CLASS II	Azelaic Acid Gel, 15% tubes, For Topical Use only recalledAzelaic Acid	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
24 Jun 2026Drug	CLASS II	Alyacen 7/7/7, Norethindrone recalled by Glenmark PharmaceuticalsAlyacen 1/35	Glenmark Pharmaceuticals Inc., USA	Potency & Assay	Nationwide
7 Jan 2026Drug	CLASS II	Ondansetron Orally Disintegrating Tablets, USP, 4mg recalledOndansetron	Glenmark Pharmaceuticals Inc., USA	Packaging Defects	Nationwide
17 Dec 2025Drug	CLASS III	Nebivolol Tablets, 20 mg recalled by Glenmark PharmaceuticalsNebivolol	Glenmark Pharmaceuticals Inc., USA	Other	Nationwide
10 Dec 2025Drug	CLASS III	Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalledBisoprolol Fumarate And Hydrochlorothiazide	Glenmark Pharmaceuticals Inc., USA	Packaging Defects	Nationwide
22 Oct 2025Drug	CLASS II	Viorele, Desogestrel and Ethinyl Estradiol recalledViorele	Glenmark Pharmaceuticals Inc., USA	Potency & Assay	Nationwide
1 Oct 2025Drug	CLASS II	Azelaic Acid Gel, 15%, For Topical Use Only recalledAzelaic Acid	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
20 Aug 2025Drug	CLASS II	Carvedilol Tablets, USP, 25 mg recalled by Glenmark PharmaceuticalsCarvedilol	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
20 Aug 2025Drug	CLASS II	Carvedilol Tablets, USP, 3.125 mg, Packaged as: a) recalledCarvedilol	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
20 Aug 2025Drug	CLASS II	Theophylline extended-release tablets 400mg recalledTheophylline	Glenmark Pharmaceuticals Inc., USA	Potency & Assay	Nationwide
20 Aug 2025Drug	CLASS II	Carvedilol Tablets, USP, 12.5 mg recalled by Glenmark PharmaceuticalsCarvedilol	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
20 Aug 2025Drug	CLASS II	Carvedilol Tablets, USP, 25 mg recalled by Glenmark PharmaceuticalsCarvedilol	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
20 Aug 2025Drug	CLASS II	Carvedilol Tablets, USP, 12.5 mg recalled by Glenmark PharmaceuticalsCarvedilol	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
18 Jun 2025Drug	CLASS III	Ezetimibe and Simvastatin Tablets, 10mg/40mg recalledEzetimibe And Simvastatin	Glenmark Pharmaceuticals Inc., USA	Potency & Assay	Nationwide
4 Jun 2025Drug	CLASS II	Carvedilol Tablets USP 6.25 mg, a.) bottle recalledCarvedilol	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
4 Jun 2025Drug	CLASS II	Carvedilol Tablets USP 3.125mg Tablets a.) bottle recalledCarvedilol	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
4 Jun 2025Drug	CLASS II	Theophylline (Anhydrous) Extended-Release Tablets, 600 mg recalledTheophylline	Glenmark Pharmaceuticals Inc., USA	Potency & Assay	Nationwide
4 Jun 2025Drug	CLASS II	Carvedilol Tablets USP 12.5 mg recalled by Glenmark PharmaceuticalsCarvedilol	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
4 Jun 2025Drug	CLASS II	Carvedilol Tablets USP 25 mg recalled by Glenmark PharmaceuticalsCarvedilol	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
16 Apr 2025Drug	CLASS II	Fluphenazine Hydrochloride Tablets 2.5mg recalledFluphenazine Hydrochloride	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Teriflunomide Tablets, 14mg recalled by Glenmark PharmaceuticalsTeriflunomide	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Solifenacin Succinate Tablets 10MG, a. bottle recalledSolifenacin Succinate	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Voriconazole Tablets 200 mg recalled by Glenmark PharmaceuticalsVoriconazole	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Propafenone Hydrochloride Extended-Release Capsules 225mg recalledPropafenone Hydrochloride	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Lacosamide Tablets, 50mg recalled by Glenmark PharmaceuticalsLacosamide	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Nitroglycerin Sublingual Tablets 0.3MG recalledNitroglycerin	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Clindamycin Hydrochloride Capsules, USP, 300mg recalledClindamycin Hydrochloride	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Indomethacin Extended-Release Capsules, 75mg recalledIndomethacin	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Rosuvastatin Tablets 40mg recalled by Glenmark PharmaceuticalsRosuvastatin Calcium	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Propafenone Hydrochloride Extended-Release Capsules, USP 325mg recalledPropafenone Hydrochloride	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.