FDA recall D-0628-2026

SUN PHARMACEUTICAL INDUSTRIES INC · Class II · drug

Product

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

Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2026-06-17
Report date
2026-07-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0628-2026