D-0628-2026 Class II Ongoing
FDA drug recall D-0628-2026 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on June 17, 2026 and is designated Class II. Reason for recall: Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets. The recall status is ongoing. Affected quantity: 3,456 30-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 1, 2026
- Initiation Date
- June 17, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,456 30-count bottles
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
Reason for Recall
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Distribution Pattern
Nationwide in the USA
Code Information
Lot AE01763, Expires 9/30/2027.