RecallRadar

FDA Drug recall D-0321-2025

Lacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, In…

On 2025-04-16 the FDA classified a Class II recall of Lacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, In… by Glenmark Pharmaceuticals Usa, citing CGMP Deviations.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0321-2025
ClassificationClass II
Statusongoing
Initiated2025-03-13
Published2025-04-16
Last updated2026-09-13 11:52 UTC
CompanyGlenmark Pharmaceuticals Usa
DistributionUS

Product

Lacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-681-60.

Reason

CGMP Deviations

Identifiers

ndc68462-678-30
ndc68462-678-60
ndc68462-678-10
ndc68462-679-30
ndc68462-679-60
ndc68462-679-10
ndc68462-680-30
ndc68462-680-60
ndc68462-680-10
ndc68462-681-30
ndc68462-681-60
ndc68462-681-10
code_info
Lot # 17230982, exp. date Apr-25 17230986, exp. date, Apr-25 17231001, exp. date, Apr-25 17240197, exp. date Jan-26 172…Lot # 17230982, exp. date Apr-25 17230986, exp. date, Apr-25 17231001, exp. date, Apr-25 17240197, exp. date Jan-26 17240198, exp. date Jan-26 17240215, exp. date Jan-26 17240846, exp. date Apr-26 17240847, exp. date Apr-26

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-0321-2025%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.