Perampanel Prescription Tablets Recalled for Labeling Mix-up
Sun Pharmaceutical is recalling Perampanel 6 mg tablets due to labeling mix-up where 10 mg tablets were found in bottles labeled as 6 mg. Patients should verify their bottles with their pharmacy or physician.
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 an FDA Class II recall involving wrong-strength tablets in prescription medication. The hazard is a risk-of-harm (patient receiving 67% higher dose than prescribed), and the source explicitly states no illnesses or injuries reported. Per the rubric, risk-of-harm products without reported injury merit a score of 3 (High).
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling Perampanel CIII tablets, 6 mg, Rx only, due to a labeling mix-up. According to the FDA, a bottle labeled as containing Perampanel 6 mg tablets was found to contain 10 mg Perampanel CIII tablets instead.
The recalled product is Lot AE01763, expiring 9/30/2027, consisting of 3,456 30-count bottles. The product was manufactured by Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel, and distributed nationwide in the USA by Sun Pharmaceutical Industries, Inc., Cranbury, NJ.
Patients who have received this medication should contact their pharmacy or healthcare provider to verify the contents of their bottles. Do not use the medication without confirmation from a healthcare professional.
The recalled product
- Product
- PERAMPANEL (PERAMPANEL)
- Brand
- PERAMPANEL
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- 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 (2)
- Lot AE01763
- Expires 9/30/2027.
UPCs (5)
- 0351672420567
- 0351672420666
- 0351672420765
- 0351672420963
- 0351672420468
Distribution
Distributed nationwide across the United States.
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