Why it was recalled
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Product description
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
Lot numbers, UPCs & expiration codes
Lot AE01763, Expires 9/30/2027.
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0628-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 17, 2026
- FDA report date
- Jul 1, 2026
- Quantity
- 3,456 30-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0628-2026, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 99256
- Address
- 2 Independence Way
- Code information
- Lot AE01763, Expires 9/30/2027.
- Postal code
- 08540-6620
- Report date
- Jul 1, 2026
- Product type
- Drugs
- Recall number
- D-0628-2026
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 3,456 30-count bottles
- Reason for recall
- Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 17, 2026
- Initial firm notification
- Letter
- Center classification date
- Jun 26, 2026