RecallRadar

FDA Drug recall D-0330-2025

Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775,…

On 2025-04-16 the FDA classified a Class II recall of Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775,… by Glenmark Pharmaceuticals Usa, citing CGMP Deviations.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0330-2025
ClassificationClass II
Statusongoing
Initiated2025-03-13
Published2025-04-16
Last updated2026-09-13 11:52 UTC
CompanyGlenmark Pharmaceuticals Usa
DistributionUS

Product

Lacosamide Tablets, 100mg , 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# 68462-679-60

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 # 17232533, exp. date Nov-25 17232534, exp. date Nov-25 17240606, exp. date Mar-26 17240619, exp. date Mar-26 1724…Lot # 17232533, exp. date Nov-25 17232534, exp. date Nov-25 17240606, exp. date Mar-26 17240619, exp. date Mar-26 17240911, exp. date May-26 17240912, exp. date May-26 17241121, exp. date Jun-26 17241124, exp. date Jun-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-0330-2025%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.