Recall: D-0337-2025

Class II - Potentially Harmful

Class IIClassification

2025-03-13Initiated

OngoingStatus

Glenmark Pharmaceuticals Inc.,Firm

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

CGMP Deviations

Distribution

U.S. Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.