Lacosamide Tablets 200mg Recalled Due to CGMP Deviations
Glenmark Pharmaceuticals is recalling Lacosamide Tablets 200mg nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall is voluntary and affects specific lot numbers with expiration dates ranging from April 2025 to April 2026.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for CGMP deviations, which are manufacturing defects. The source text does not report any illnesses, injuries, or clinical consequences, making this a precautionary/low-risk contamination scenario rather than a confirmed hazard recall.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Lacosamide Tablets 200mg, 60-count bottles nationwide. The recall was initiated on March 13, 2025, due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing.
The affected product is Lacosamide (generic name) Tablets 200mg, NDC# 68462-681-60, manufactured by Glenmark Pharmaceuticals Limited in Pithampur, Madhya Pradesh, India, and manufactured for Glenmark Pharmaceuticals Inc. USA in Mahwah, NJ. Eight specific lot numbers are affected: 17230982, 17230986, 17231001, 17240197, 17240198, 17240215, 17240846, and 17240847, with expiration dates ranging from April 2025 to April 2026.
This is a voluntary, firm-initiated recall. Lacosamide is a prescription antiepileptic drug. Patients currently taking affected lots should consult their healthcare provider or pharmacist regarding the recall. The FDA classified this as a Class II recall on April 8, 2025.
The recalled product
- Product
- LACOSAMIDE (LACOSAMIDE)
- Brand
- LACOSAMIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Antiepileptic Tablets
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Lot # 17230982
- exp. date Apr-25 17230986
- exp. date
- Apr-25 17231001
- 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
UPCs (4)
- 0368462681602
- 0368462679609
- 0368462678602
- 0368462680605
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 39 recalled by Glenmark Pharmaceuticals Inc., USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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