Recall: D-0731-2026

Class II - Potentially Harmful

Class IIClassification

2026-07-23Initiated

OngoingStatus

Glenmark Pharmaceuticals Inc.,Firm

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.

Distribution

Nationwide within the United States.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.