CETIRIZINE HYDROCHLORIDE
Recalling Firm / Manufacturer: JB Chemicals and Pharmaceuticals Ltd
(Mumbai, India)
FDA Recall Number: D-0033-2026
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)
16571-402
Total Quantity Recalled
13,440 bottles
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Tablet/Capsules Imprinted with Wrong ID
Full Product Description
Packaging specifications and labeling details
Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, 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 16571-402-50
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class III
Current Action Status
Ongoing
FDA Enforcement Report Date
October 29, 2025
Firm Initiation Date
September 12, 2025
FDA Classification Date
Oct 17, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot # PY925014, PY925013, Exp. 1/31/2028
Distribution Information
Geographic scope of affected shipments
U.S. Nationwide
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Advisory Notice
This Class III recall involves technical or packaging non-conformities that are not expected to cause adverse health consequences. Consult your pharmacist if you have questions.
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-0033-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508611UTCC