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.
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 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.
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FDA (Drugs) · 2023-08-30
- HighRufinamide 200 mg Tablets Recalled for Manufacturing Process Deviation
FDA (Drugs) · 2023-08-30
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