Glenmark Pharmaceuticals Inc., U recalls

Glenmark Pharmaceuticals Inc., U 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., u is recalled

Product types

Brands

By year

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

Ongoing glenmark pharmaceuticals inc., u 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., U	Foreign Material	Nationwide
24 Jun 2026Drug	CLASS II	Alyacen 7/7/7, Norethindrone recalled by Glenmark PharmaceuticalsAlyacen 1/35	Glenmark Pharmaceuticals Inc., U	Potency & Assay	Nationwide
7 Jan 2026Drug	CLASS II	Ondansetron Orally Disintegrating Tablets, USP, 4mg recalledOndansetron	Glenmark Pharmaceuticals Inc., U	Packaging Defects	Nationwide
17 Dec 2025Drug	CLASS III	Nebivolol Tablets, 20 mg recalled by Glenmark PharmaceuticalsNebivolol	Glenmark Pharmaceuticals Inc., U	Other	Nationwide
10 Dec 2025Drug	CLASS III	Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalledBisoprolol Fumarate And Hydrochlorothiazide	Glenmark Pharmaceuticals Inc., U	Packaging Defects	Nationwide
22 Oct 2025Drug	CLASS II	Viorele, Desogestrel and Ethinyl Estradiol recalledViorele	Glenmark Pharmaceuticals Inc., U	Potency & Assay	Nationwide

All glenmark pharmaceuticals inc., u 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., U	Foreign Material	Nationwide
24 Jun 2026Drug	CLASS II	Alyacen 7/7/7, Norethindrone recalled by Glenmark PharmaceuticalsAlyacen 1/35	Glenmark Pharmaceuticals Inc., U	Potency & Assay	Nationwide
7 Jan 2026Drug	CLASS II	Ondansetron Orally Disintegrating Tablets, USP, 4mg recalledOndansetron	Glenmark Pharmaceuticals Inc., U	Packaging Defects	Nationwide
17 Dec 2025Drug	CLASS III	Nebivolol Tablets, 20 mg recalled by Glenmark PharmaceuticalsNebivolol	Glenmark Pharmaceuticals Inc., U	Other	Nationwide
10 Dec 2025Drug	CLASS III	Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalledBisoprolol Fumarate And Hydrochlorothiazide	Glenmark Pharmaceuticals Inc., U	Packaging Defects	Nationwide
22 Oct 2025Drug	CLASS II	Viorele, Desogestrel and Ethinyl Estradiol recalledViorele	Glenmark Pharmaceuticals Inc., U	Potency & Assay	Nationwide
1 Oct 2025Drug	CLASS II	Azelaic Acid Gel, 15%, For Topical Use Only recalledAzelaic Acid	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
20 Aug 2025Drug	CLASS II	Carvedilol Tablets, USP, 25 mg recalled by Glenmark PharmaceuticalsCarvedilol	Glenmark Pharmaceuticals Inc., U	Nitrosamine Impurity	Nationwide
20 Aug 2025Drug	CLASS II	Carvedilol Tablets, USP, 125 mg, Packaged as: a) recalledCarvedilol	Glenmark Pharmaceuticals Inc., U	Nitrosamine Impurity	Nationwide
20 Aug 2025Drug	CLASS II	Theophylline extended-release tablets 400mg recalledTheophylline	Glenmark Pharmaceuticals Inc., U	Potency & Assay	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.