CETIRIZINE HYDROCHLORIDE
Recalling Firm / Manufacturer: JB Chemicals and Pharmaceuticals Ltd
(Mumbai, India)
FDA Recall Number: D-0732-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
CETIRIZINE HYDROCHLORIDE
Generic Name
CETIRIZINE HYDROCHLORIDE
Active Substance(s)
Cetirizine Hydrochloride
Administration Route
Oral
National Drug Code (NDC)
16571-401
Total Quantity Recalled
34,020 100-count bottles.
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
Full Product Description
Packaging specifications and labeling details
Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-401-10.
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class I
Current Action Status
Ongoing
FDA Enforcement Report Date
July 29, 2026
Firm Initiation Date
June 24, 2026
FDA Classification Date
Aug 03, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT
Distribution Information
Geographic scope of affected shipments
Nationwide in the USA
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
⚠️ Immediate Action Required — Patient Notice
According to official FDA guidelines for Class I recalls, patients using affected lots should stop taking this product immediately and contact their physician or pharmacist for an appropriate alternative. Do not dispose of medication until instructed by your pharmacy.
Healthcare Provider & Pharmacy Notice
Quarantine affected inventory immediately. Contact patients who were dispensed recalled lots to arrange replacement. Report any adverse reactions directly to the FDA MedWatch Safety Information Program.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0732-2026
Questo Retrieval Date: September 10, 2026 12:00 1789041619UTCC