Recall D-0731-2026

US Class II Ongoing · initiated 2026-07-23

Recalling firm

Glenmark Pharmaceuticals Inc., USA, NJ

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 for recall

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

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