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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 numberBatch # 19252524, Exp Date: May 2027
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: Market complaints received for gritty texture (grainy)

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 Limited Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430 foreign manufacturer
Brand nameAZELAIC ACID
Generic nameAZELAIC ACID
Active ingredient(s)AZELAIC ACID
Distributed by / forGlenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430
NDC68462-626-52
Show the full FDA record
Full product labelAzelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52
Recalling firmGlenmark Pharmaceuticals Inc., USA
DistributionNationwide within the United States
Quantity13824 tubes
Recall initiated2025-09-17
Report date2025-10-01
Recall completed—
Recall numberD-0662-2025
ClassificationClass II
FDA statusOngoing
Origin on fileMahwah 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.