FDA Recalls Lacosamide Tablets for Manufacturing Quality Deviations
Glenmark Pharmaceuticals is recalling Lacosamide 150mg tablets nationwide due to manufacturing quality deviations. Consumers should contact their pharmacy or healthcare provider regarding their supply.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is a manufacturing process deviation that represents a theoretical risk rather than a documented safety event, placing this at High severity per the rubric criterion for theoretical hazards without reported harm.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Lacosamide Tablets 150mg in 60-count bottles due to Current Good Manufacturing Practice (CGMP) deviations identified in the manufacturing process.
The recall affects product distributed nationwide. Specific recalled lots are: Lot 17241125 (expiring June 2026), Lot 17242202 (expiring November 2026), and Lot 17242204 (expiring December 2026). The National Drug Code for the recalled product is 68462-680-60.
Lacosamide is a prescription anti-seizure medication. No illnesses or injuries have been reported in connection with this recall. This is a voluntary recall initiated by the firm.
Consumers who have purchased affected lots should contact Glenmark Pharmaceuticals or their healthcare provider for guidance regarding their medication supply.
The recalled product
- Product
- LACOSAMIDE (LACOSAMIDE)
- Brand
- LACOSAMIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Anti-seizure Medication
- Hazard
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 (4)
- Lot # 17241125
- exp. date Jun-26 17242202
- exp. date Nov-26 17242204
- exp. date Dec-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.
See all 39 products in this recall →Related recalls
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