Rufinamide Tablets Recalled Due to Manufacturing Quality Deviation
Aurobindo Pharma USA Inc. is recalling Rufinamide 400 mg tablets due to manufacturing quality deviations. The affected batch was released prior to approval.
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: FDA Class II recall with no reported illnesses or injuries. This is a precautionary regulatory recall for manufacturing quality deviations (cGMP violations), not an active documented safety threat.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling 48 bottles of Rufinamide (Rufinamide) 400 mg tablets, USP, packaged in 120-count bottles. The affected lot is RB4023002A with an expiration date of 02/2025. This is a prescription medication manufactured in India and distributed nationwide in the United States.
The recall was initiated due to manufacturing quality deviations identified as good manufacturing practice (cGMP) violations. Specifically, the batch was released prior to receiving proper approval. No illnesses or injuries have been reported to date.
Patients currently taking this medication should contact their healthcare provider or pharmacist for guidance. They should not discontinue their medication without consulting their healthcare provider, as abrupt cessation of rufinamide could have medical consequences.
The recalled product
- Product
- RUFINAMIDE (RUFINAMIDE)
- Brand
- RUFINAMIDE
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug
- Hazard
- manufacturing-quality-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 (2)
- Lot #: RB4023002A
- Exp 02/2025
UPCs (1)
- 0359651616086
Distribution
Distributed nationwide across the United States.
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