FDA-Drug2026-07-01Class IIMISBRANDING

Sun Pharmaceutical Perampanel 6mg tablets recalled for label mix-up with 10mg tablets

LABEL MIX UPNationwide distribution

Sun Pharmaceutical Perampanel recalled for tablet strength mix-up

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.
Hazard

Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.

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-0628-2026

More SUN PHARMACEUTICAL INDUSTRIES INC recalls

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief