FDA Recall D-0322-2025
Glenmark Pharmaceuticals Inc., USA · Mahwah, NJ
Class II Ongoing 427 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Frovatriptan Succinate Tablets 2.5mg, 9-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-694-97
Reason for recall
CGMP Deviations
Recall record
- Recall number
D-0322-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- U.S. Nationwide
- Recall initiated
- 2025-03-13
- Classified by FDA Center
- 2025-04-08
- FDA published
- 2025-04-16
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Firm location
- Mahwah, NJ
Drug identification
- Brand name(s)
- FROVATRIPTAN SUCCINATE
- Generic name(s)
- FROVATRIPTAN SUCCINATE
- Manufacturer(s)
- Glenmark Pharmaceuticals Inc., USA
- NDC(s)
68462-694- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.