FDAFDA · Food and drugs·Recall number D-0662-2025
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
Published October 1, 2025 · Recall initiated: September 17, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Market complaints received for gritty texture (grainy)
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- AZELAIC ACID
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Distributor
- Nationwide within the United States
- UPC
- 0368462626528
- Lot
- Batch # 19252524, Exp Date: May 2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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