Lacosamide 50mg Tablets Recalled for Manufacturing Process Deviations
Glenmark Pharmaceuticals is recalling Lacosamide 50mg tablets nationwide due to manufacturing process deviations. The affected lots (17240221 and 17240222) expire January 2026. No illnesses reported.
What this means for you
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: This FDA Class II recall involves manufacturing process deviations in a prescription antiepileptic medication. Although no illnesses or injuries have been reported, CGMP violations represent a risk-of-harm product scenario. The score is capped at 3 per the rubric rule for theoretical hazards with no documented harm.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Lacosamide 50mg tablets in 60-count bottles nationwide. The affected lots are 17240221 and 17240222, both with expiration dates in January 2026. The product is manufactured by Glenmark Pharmaceuticals Limited in India and distributed under the brand name LACOSAMIDE.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified at the manufacturing facility. The firm discovered these deviations and voluntarily initiated the recall on March 13, 2025. No illnesses or injuries related to this product have been reported.
Patients taking this medication should not stop treatment abruptly without consulting their healthcare provider, as Lacosamide is used to treat epilepsy. Those with affected lot numbers should contact their pharmacist or Glenmark Pharmaceuticals for guidance on replacement options or alternative treatments.
The recalled product
- Product
- LACOSAMIDE (LACOSAMIDE)
- Brand
- LACOSAMIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Anticonvulsant
- Hazard
- cgmp-deviation
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.
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