Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmace...
FDA Recall #D-0033-2026 — Class III — September 12, 2025
Product Description
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
Reason for Recall
Tablet/Capsules Imprinted with Wrong ID
Recalling Firm
JB Chemicals and Pharmaceuticals Ltd — Mumbai
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
13,440 bottles
Distribution
U.S. Nationwide
Code Information
Lot # PY925014, PY925013, Exp. 1/31/2028
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated