Sun Pharmaceutical Industries Inc: Fexofenadine Hydrochloride Tablets, Usp 180 Mg, Antihistamine, 150 Tablets Per Bottle

Recall Summary Sun Pharmaceutical is recalling Fexofenadine Hydrochloride Tablets 180 mg (an allergy medication sold in 150-tablet bottles under NDC 66336-561-30 and distributed by Ohm Laboratories) that was distributed nationwide because the tablets failed quality tests for impurities and degradation. The affected product was available throughout the United States. This is a Class III recall, which means the product is unlikely to cause serious harm but does not meet quality standards.

Recalling firm

SUN PHARMACEUTICAL INDUSTRIES INC

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

Failed Impurities/Degradation Specifications

Classification

Class III

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-06-01

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

U.S. Nationwide

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/bd08c52e-3f6f-4d87-a647-d49e5c93253c