FDA Drug Recalls

Recalls / Active ingredient / Cetirizine Hydrochloride

Cetirizine Hydrochloride

10 FDA drug recalls involving the active ingredient “Cetirizine Hydrochloride.

DateClassProductFirm
2025-09-12Class IIICetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs,JB Chemicals and Pharmaceuticals Ltd
2025-09-12Class IIICetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs,JB Chemicals and Pharmaceuticals Ltd
2025-03-13Class IICetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark TherapeuticsGlenmark Pharmaceuticals Inc., USA
2021-10-05Class IIICetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S Medications Solutions, LibertyviA-S Medication Solutions LLC.
2018-10-19Class IIchildren's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FTaro Pharmaceuticals U.S.A., Inc.
2017-04-18Class IIIChildren's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, Manufactured by: Sun PharmaceuticSun Pharmaceutical Industries, Inc.
2015-09-28Class IIICetirizine HCl 10 mg Tablet, 14 count blister packs, sold over the counter under the following brands, GoodSenPerrigo Company PLC
2014-04-09Class IIICetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, IndCaraco Pharmaceutical Laboratories, Ltd.
2014-04-09Class IIIChildren's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun PharmCaraco Pharmaceutical Laboratories, Ltd.
2012-09-20Class IIIChildren's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz PrivatSandoz Incorporated