Rufinamide 200 mg Tablets Recalled for Manufacturing Process Deviation
Aurobindo Pharma USA Inc. is recalling Rufinamide 200 mg tablets (Lot RB2023001A) because a batch was released prior to manufacturing approval. The FDA classified this as a Class II recall.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is classified as High severity because it involves a prescription medication released without proper manufacturing approval, meeting the rubric criterion for risk-of-harm products where injury has not been reported. Although no illnesses or injuries have been reported, the FDA's Class II designation indicates potential for adverse health consequences.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling Rufinamide 200 mg tablets due to manufacturing process deviations. The recalled batch (Lot RB2023001A, expiration 02/2025) was released for distribution prior to receiving manufacturing approval. The FDA classified this as a Class II recall.
The product was distributed nationwide in the United States. Approximately 48 bottles of Rufinamide in 120-count packaging were affected. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- RUFINAMIDE (RUFINAMIDE)
- Brand
- RUFINAMIDE
- Manufacturer
- Aurobindo Pharma USA Inc.
- Hazard
- Affected units
- 48
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 #: RB2023001A
- Exp 02/2025
UPCs (1)
- 0359651616086
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Aurobindo Pharma USA Inc. 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 2 products in this recall →Related recalls
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