Recalls / Class II
Class IID-0662-2025
Product
Azelaic 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
- Brand name
- Azelaic Acid
- Generic name
- Azelaic Acid
- Active ingredient
- Azelaic Acid
- Route
- Topical
- NDC
- 68462-626
- FDA application
- ANDA204637
- Affected lot / code info
- Batch # 19252524, Exp Date: May 2027
Why it was recalled
CGMP Deviations: Market complaints received for gritty texture (grainy)
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 13824 tubes
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2025-09-17
- FDA classified
- 2025-09-24
- Posted by FDA
- 2025-10-01
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0662-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.