FDA recall D-0337-2025

Glenmark Pharmaceuticals Inc., USA · Class II · drug

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

Reason for recall

CGMP Deviations

Distribution

U.S. Nationwide

Key facts

Status: Ongoing
Initiation date: 2025-03-13
Report date: 2025-04-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0337-2025