Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0323-2025·Announced 2025-04-16

Glenmark Rufinamide Tablets Recalled for Manufacturing Process Deviations

Glenmark Pharmaceuticals is recalling Rufinamide 200mg tablets nationwide due to manufacturing process deviations. The voluntary recall affects certain lot numbers with July 2025 expiration dates.

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: This is a Class II FDA recall for manufacturing process deviations with no reported illnesses or injuries. Per the rubric, Class II recalls without hospitalization reports and no reported adverse events are classified as Moderate.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Rufinamide 200mg tablets due to deviations in manufacturing processes that do not meet Current Good Manufacturing Practice (CGMP) standards. The recall was initiated on March 13, 2025, and affects nationwide distribution.

Affected product: Rufinamide Tablets 200mg, 120-count bottles (NDC# 68462-713-08). The recall involves Lot #17231643 and Lot #17231644, both with an expiration date of July 2025. These tablets are prescription-only medications manufactured by Glenmark Pharmaceuticals Limited in India for Glenmark Pharmaceuticals Inc. USA.

Consumers taking this medication should contact their healthcare provider or pharmacist to determine if they have affected product and discuss alternatives or replacement supplies. Do not stop taking this medication without consulting your healthcare provider, as abrupt discontinuation of anti-seizure medication can pose serious health risks.

The recalled product

Product: RUFINAMIDE (RUFINAMIDE)
Brand: RUFINAMIDE
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Category: Drug — Anticonvulsant
Hazard: cgmp-deviation
quality-defect

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 # 17231643
exp. date Jul-25 17231644
exp. date Jul-25

UPCs (2)

0368462714089
0368462713082

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 →

Same brand · RUFINAMIDE

High
Rufinamide 200 mg Tablets Recalled for Manufacturing Process Deviation
FDA (Drugs) · 2023-08-30
Moderate
Rufinamide Tablets Recalled Due to Manufacturing Quality Deviation
FDA (Drugs) · 2023-08-30

Same manufacturer · Glenmark Pharmaceuticals Inc., USA

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