Lacosamide Tablets 50mg Recalled for CGMP Manufacturing Deviations
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Lacosamide Tablets 50mg due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects specific lots distributed nationwide.
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: The recall is FDA Class II for CGMP deviations without any reported illnesses or injuries. Under the rubric, Class II recalls without hospitalization reports are typically Moderate severity.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Lacosamide Tablets, 50mg, in 60-count bottles (NDC# 68462-678-60) due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The affected lots are #17240221 and #17240222, both with expiration date January 2026.
The product was distributed nationwide in the United States. Lacosamide is a prescription oral medication used to treat seizures. The FDA has classified this recall as Class II.
Patients currently taking Lacosamide from affected lots should contact their healthcare provider or pharmacist before stopping the medication. Healthcare providers and patients should report any adverse events to the FDA's MedWatch program.
The recalled product
- Product
- LACOSAMIDE (LACOSAMIDE)
- Brand
- LACOSAMIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
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 (3)
- Lot # 17240221
- exp. date Jan-26 17240222
- exp. date Jan-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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