FDA Drug recall D-0662-2025
Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 40351…
- FDA Drug
- Class II
- ongoing
- Published 2025-10-01
On 2025-10-01 the FDA classified a Class II recall of Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 40351… by Glenmark Pharmaceuticals Usa, citing CGMP Deviations: Market complaints received for gritty texture (grainy).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0662-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-17 |
| Published | 2025-10-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
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
Reason
CGMP Deviations: Market complaints received for gritty texture (grainy)
Identifiers
| ndc | 68462-626-52 |
|---|---|
| code_info | Batch # 19252524, Exp Date: May 2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0662-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.