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Glenmark Pharmaceuticals Inc., USA

2 recalls on record · Last recall: Jul 23, 2026

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Records, not a safety rating.

Recall counts do not account for sales volume, exposure or differences in reporting. Agency records can overlap. A low count does not establish that a brand or product is safe.

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Severity Breakdown

Class I — Serious
0
Class II — Moderate
2
Class III — Low Risk
0

Categories

MEDICATION

Recall Timeline

Class IIFDAJul 23, 2026

Glenmark Pharmaceuticals Inc., USA — CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.

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. CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.

Class IIFDAMay 27, 2026

Glenmark Pharmaceuticals Inc., USA — Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.

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, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430, NDC 68462-556-29 Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.

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