FDA recall D-0654-2026

SUN PHARMACEUTICAL INDUSTRIES INC · Class III · drug

Product

Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswick, NJ 08901. NDC 66336-561-30

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

U.S. Nationwide

Key facts

Status: Ongoing
Initiation date: 2026-06-01
Report date: 2026-07-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0654-2026