Glenmark Pharmaceuticals Inc., USA recalls Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA,

Recalled August 5, 2026 · FDA recall D-0731-2026 · Glenmark Pharmaceuticals Inc., USA

Hazard

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

Units

N/A

Sold at

Nationwide within the United States.

Description

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

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.

Manufacturer(s)

Glenmark Pharmaceuticals Inc., USA

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →