Glenmark Pharmaceuticals Inc., USA Azelaic Acid Gel, 15% Recall
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 |
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.
How to identify the recalled item
| Lot / date codes | Lot #: 19260937A, Exp. Date February 2028; 19261225A, 19261185A, Exp. Date March 2028; 19261664A, 19261682A, Exp. Date April 2028. |
|---|---|
| Lot / date codes | Lot #: 19260937A, Exp. Date February 2028; 19261225A, 19261185A, Exp. Date March 2028; 19261664A, 19261682A, Exp. Date April 2028. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other Glenmark Pharmaceuticals Inc., USA recalls
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.