FDA-Drug2026-07-01Class IIMISBRANDING
Sun Pharmaceutical Perampanel 6mg tablets recalled for label mix-up with 10mg tablets
What this means
Sun Pharmaceutical discovered that some bottles labeled as containing 6mg Perampanel tablets actually contained 10mg tablets instead. This mix-up affects one lot (AE01763) distributed nationwide. Patients taking the wrong strength could receive an incorrect dose of this seizure medication.
- Check if you have Perampanel with lot number AE01763 and expiration date 9/30/2027.
- Do not take any tablets from the affected bottle without confirming the actual tablet strength with your pharmacy or doctor.
- Contact your pharmacy or healthcare provider immediately if you have this lot.
- Return the bottle to your pharmacy for verification and replacement if needed.
The agency's original wording
Hazard
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA
Affected count
3,456 30-count bottles
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 51672-4206-6
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0628-2026Want us to check the next one for you?
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