FDAHealthSeptember 17, 2025
Glenmark Pharmaceuticals Inc., USA — Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India, Manufactured f
⚠️ CGMP Deviations: Market complaints received for gritty texture (grainy)
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 17, 2025
Nationwide within the United States
What's affected?
- 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
- AZELAIC ACID
- UPC
- 0368462626528
- Lot code
- Batch # 19252524, Exp Date: May 2027
Additional details
Batch # 19252524, Exp Date: May 2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 13824 tubes.
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