Glenmark Recalls Azelaic Acid Gel 15% Over Grainy Texture Complaints

Glenmark Pharmaceuticals Inc., USA had one notable regulatory item during the week, a drug recall classified by the FDA.

• Glenmark Pharmaceuticals Inc., USA is recalling Azelaic Acid Gel, 15%, due to CGMP deviations after product quality complaints described abnormal texture or consistency, including grainy, gritty, or sandy characteristics.¹ The firm initiated the recall on July 23, 2026, from its Elmwood Park, NJ facility, and the FDA classified it as Class II on July 28, 2026.¹ The affected 50 gram tubes are for topical use only, distributed nationwide under NDC 68462-626-52, and the recall remains ongoing as of the report date.¹