Information
SUN PHARMACEUTICAL INDUSTRIES INC Recalls Fexofenadine Hydrochloride Tablets
This is a Class III recall. This product is unlikely to cause adverse health reactions but violates FDA regulations.
Source: FDA
InfoRecall #D-0654-2026Drug / Pharmaceutical
SUN PHARMACEUTICAL INDUSTRIES INC Recalls Fexofenadine Hydrochloride Tablets
SUN PHARMACEUTICAL INDUSTRIES INC · Class III — Regulatory
Product Description
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
FDA Classification
Class III — Regulatory
A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Distribution
U.S. Nationwide
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
A regulatory compliance recall has been issued for a pharmaceutical product from SUN PHARMACEUTICAL INDUSTRIES INC. The FDA classified this as Class III on June 1, 2026 affecting 9,048 bottles. Failed Impurities/Degradation Specifications. It was distributed in U.S. Nationwide. While this classification indicates a low probability of adverse health effects, consumers should be aware of the recall and follow any instructions from the manufacturer.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.