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Class II · ModerateActive recall

Azelaic Acid

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 19260937A, Exp. Date February 2028; 19261225A, 19261185A, Exp. Date March 2028; 19261664A, 19261682A, Exp. Date April 2028.
Where it was soldNationwide within the United States.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byGlenmark Pharmaceuticals Inc., USA
Brand nameAZELAIC ACID
Generic nameAZELAIC ACID
Active ingredient(s)AZELAIC ACID
Distributed by / forGlenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407
NDC68462-626-52
Show the full FDA record
Full product labelAzelaic 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.
Recalling firmGlenmark Pharmaceuticals Inc., USA
DistributionNationwide within the United States.
QuantityN/A
Recall initiated2026-07-23
Report date2026-08-05
Recall completed—
Recall numberD-0731-2026
ClassificationClass II
FDA statusOngoing
Origin on fileElmwood Park NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.