Glenmark Pharmaceuticals Inc., Usa: Azelaic Acid Gel, 15%, 50 Gram Tubes, For Topical Use Only

Azelaic Acid Gel Recall Summary Glenmark Pharmaceuticals is recalling Azelaic Acid Gel 15% (50-gram tubes) distributed nationwide because some tubes have an abnormal texture—appearing grainy, gritty, or sandy instead of the normal smooth consistency. The affected product is a prescription topical gel used to treat skin conditions. This recall was classified as Class II, meaning the product quality issue is unlikely to cause serious health consequences, but the product does not meet manufacturing standards.

Recalling firm

Glenmark Pharmaceuticals Inc., USA

Product

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.

Reason

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

Classification

Class II

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-07-23

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

Nationwide within the United States.

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/c8c7a985-d21b-460a-a502-2e3ef3a13705