Lacosamide Tablets Recalled Due to Manufacturing Practice Deviations
Glenmark Pharmaceuticals is recalling Lacosamide 100mg tablets nationwide due to manufacturing practice deviations. This is a voluntary recall initiated by the manufacturer.
What this means for you
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 initiated by the firm as a precautionary measure due to CGMP deviations, with no reported illnesses or injuries. Per the rubric, voluntary precautionary recalls are classified as Moderate (score 2).
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Lacosamide Tablets, 100mg, distributed nationwide due to Good Manufacturing Practice (CGMP) deviations. The recall is voluntary and was initiated by the manufacturer.
The affected product is supplied in 60-count bottles with lot numbers 17232533, 17232534, 17240606, 17240619, 17240911, 17240912, 17241121, and 17241124, with expiration dates ranging from November 2025 to June 2026. The product is manufactured by Glenmark Pharmaceuticals Limited in Pithampur, Madhya Pradesh, India, and distributed by Glenmark Pharmaceuticals Inc. USA in Mahwah, New Jersey.
The FDA classified this recall as Class II. The recall was initiated on March 13, 2025, with FDA notification on April 16, 2025. This is a precautionary measure by the manufacturing firm to address manufacturing practice deviations.
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 (9)
- 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
UPCs (4)
- 0368462681602
- 0368462679609
- 0368462678602
- 0368462680605
Distribution
Distributed nationwide across the United States.
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