Glenmark Pharmaceuticals Inc., USA Azelaic Acid Gel, 15% Recall (February 2028)
Announced 2026-08-05 · FDA
FDA is recalling Glenmark Azelaic Acid Gel, 15%, 50 gram tubes distributed nationwide due to CGMP deviations and reports of abnormal texture (grainy, gritty, or sandy). The affected lots are 19260937A (Exp February 2028); 19261225A and 19261185A (Exp March 2028); and 19261664A and 19261682A (Exp April 2028).
| Brand | Glenmark Pharmaceuticals Inc., USA |
|---|---|
| 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 | CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received. |
| Severity | moderate |
| Units affected | N/A |
| Distribution | Nationwide within the United States. |
| Agency | FDA |
| Recall / campaign no. | Lot #: 19260937A, Exp. Date February 2028; 19261225A, 19261185A, Exp. Date March 2028; 19261664A, 19261682A, Exp. Date April 2028. |
WHAT YOU SHOULD DO
- Stop using any Azelaic Acid Gel from the recalled lots and remove it from your medicine cabinet.
- Check the lot number on your tube against the recalled lots listed and discard or return if it matches.
- Contact Glenmark Pharmaceuticals Inc., USA for instructions on recall procedures, replacement, or refund.
- If you have medical concerns, consult your healthcare professional.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.