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.

FDA recall notice · announced August 5, 2026 · Glenmark Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide within the United States.
Lot/code information: Lot #: 19260937A, Exp. Date February 2028; 19261225A, 19261185A, Exp. Date March 2028; 19261664A, 19261682A, Exp. Date April 2028.
Quantity: N/A
Status: Ongoing
Products in this recall event:
- 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. (D-0731-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.