The Recall Desk
ModerateFDA (Drugs)·D-0330-2025·Announced 2025-04-16

Glenmark Lacosamide 100mg Tablets Recalled for CGMP Deviations

Glenmark Pharmaceuticals is recalling Lacosamide 100mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The firm initiated this voluntary recall on March 13, 2025.

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: The source text indicates an FDA Class II recall for CGMP deviations with no reported illnesses or injuries. CGMP deviations represent a manufacturing process defect; under the rubric, a Class II recall without hospitalization reports defaults to a Moderate rating (score 2).

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is recalling Lacosamide 100mg tablets, 60-count bottles, nationwide. The product is manufactured by Glenmark Pharmaceuticals Limited in Pithampur, Madhya Pradesh, India, and distributed by Glenmark Pharmaceuticals Inc. USA in Mahwah, NJ. The recall affects NDC# 68462-679-60 and multiple lot numbers with expiration dates ranging from November 2025 to June 2026.

The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations. Lacosamide is a prescription oral medication used to decrease central nervous system disorganized electrical activity.

Affected lot numbers include: 17232533, 17232534, 17240606, 17240619, 17240911, 17240912, 17241121, and 17241124, with expiration dates between November 2025 and June 2026. Patients taking this medication should contact their healthcare provider or pharmacist if they have questions or concerns about their supply.

This is a voluntary recall initiated by the firm. The FDA classified this as a Class II recall and the recall was initiated on March 13, 2025.

The recalled product

Product
LACOSAMIDE (LACOSAMIDE)
Brand
LACOSAMIDE
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug — Prescription Oral 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 (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.

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 →

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