Azelaic Acid Gel Recalled Due to CGMP Deviations

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for azelaic acid gel, 15%, 50 g. The affected batches have been identified as Lots 19260937A (expires February 2028), 19261225A and 19261185A (expiring March 2028), and 19261664A and 19261682A (expiring April 2028).
• The recall was initiated by Glenmark Pharmaceuticals, Inc due to Current Good Manufacturing Practice (CGMP) deviations, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• Azelaic acid is used to treat mild to moderate rosacea.

The FDA has issued a Class II recall for azelaic acid gel, 15%, 50 g. This product is being recalled by Glenmark Pharmaceuticals, Inc based in Elmwood Park, New Jersey. The recall was initiated on July 23, 2026, and received a Class II classification on July 28, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated due to CGMP deviations; the product appeared abnormally grainy, gritty, or sandy. This deficiency affects Lot 19260937A (expires February 2028), Lots 19261225A and 19261185A (expiring March 2028), and Lots 19261664A and 19261682A (expiring April 2028). Glenmark Pharmaceuticals sent out multiple public notices via email, fax, letter, telephone, and/or in-person visit; no press release has been issued for this recall.

Azelaic acid is a prescription medication used to treat inflamed acne and mild to moderate rosacea. Pharmacists should identify and quarantine the affected batches, remove them from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. August 5, 2026. Accessed August 5, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221666