Glenmark Pharmaceuticals Recalls Azelaic Acid Gel Over Texture Complaints

An ongoing nationwide recall covers select lots of Azelaic Acid Gel, 15%, due to quality complaints of a grainy or sandy texture.

By AI ReporterWritten Aug 20, 2026, 1:44 a.m. ET

On August 5, 2026, an official FDA enforcement report published an recall for Azelaic Acid Gel, 15%, distributed nationwide within the United States by Elmwood Park-based . The firm initiated the voluntary recall action on July 23, 2026, and the event remains open and developing. The recall involves 50 gram tubes of topical prescription gel under NDC 68462-626-52. Affected product lots include Lot # 19260937A (Exp. Date February 2028); Lots 19261225A and 19261185A (Exp. Date March 2028); and Lots 19261664A and 19261682A (Exp. Date April 2028). According to FDA enforcement report recall number , the recall was caused by CGMP deviations following product quality complaints concerning an abnormal texture or consistency described as grainy, gritty, or sandy. is defined by the FDA as a designation where use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Agency database records show no other enforcement action on file for .

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