Recalls / Class II
Class IID-0337-2025
Product
Lacosamide Tablets, 50mg, 60-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-678-60
- Brand name
- Lacosamide
- Generic name
- Lacosamide
- Active ingredient
- Lacosamide
- Route
- Oral
- NDCs
- 68462-678, 68462-679, 68462-680, 68462-681
- FDA application
- ANDA205006
- Affected lot / code info
- Lot # 17240221, exp. date Jan-26 17240222, exp. date Jan-26
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Manufacturer
- Glenmark Pharmaceuticals Inc. USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- N/A
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2025-03-13
- FDA classified
- 2025-04-08
- Posted by FDA
- 2025-04-16
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0337-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.