FDA recall D-0770-2026

SUN PHARMACEUTICAL INDUSTRIES INC · Class II · drug

Product

Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3.

Reason for recall

CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing

Distribution

US Nationwide.

Key facts

Status
Ongoing
Initiation date
2026-08-03
Report date
2026-08-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0770-2026