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
Reported: October 1, 2025 Initiated: September 17, 2025 #D-0662-2025
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
Reason for Recall
CGMP Deviations: Market complaints received for gritty texture (grainy)
Details
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Units Affected
- 13824 tubes
- Distribution
- Nationwide within the United States
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: 13824 tubes.
Why was this product recalled? ▼
CGMP Deviations: Market complaints received for gritty texture (grainy)
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 1, 2025. Severity: Moderate. Recall number: D-0662-2025.
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