Glenmark Pharmaceuticals Inc., Usa: Azelaic Acid Gel, 15%, 50 Gram Tubes, For Topical Use Only

Recall Summary Glenmark Pharmaceuticals is recalling Azelaic Acid Gel 15% (50-gram tubes) distributed nationwide because some batches have an abnormal texture described as grainy, gritty, or sandy due to manufacturing quality issues. The product is a prescription-only topical medication. This is a Class II recall, meaning the product could cause adverse health effects.

Recalling firm

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.

Classification

Class II

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-07-23

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

Nationwide within the United States.

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/40b0f03a-8c02-40c0-8d4b-920aa2e60392