Why it was recalled
CGMP Deviations: Market complaints received for gritty texture (grainy)
Product description
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
Lot numbers, UPCs & expiration codes
Batch # 19252524, Exp Date: May 2027
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0662-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 17, 2025
- FDA report date
- Oct 1, 2025
- Quantity
- 13824 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-0662-2025, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97619
- Address
- 750 Corporate Dr
- Code information
- Batch # 19252524, Exp Date: May 2027
- Postal code
- 07430-2009
- Report date
- Oct 1, 2025
- Product type
- Drugs
- Recall number
- D-0662-2025
- Classification
- Class II
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Product quantity
- 13824 tubes
- Reason for recall
- CGMP Deviations: Market complaints received for gritty texture (grainy)
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Sep 17, 2025
- Initial firm notification
- Letter
- Center classification date
- Sep 24, 2025