Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. o
Summary
The FDA issued a Class III for Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by by JB Chemicals and Pharmaceuticals Ltd. Reason: Tablet/Capsules Imprinted with Wrong ID.
Details
Source
Drug Recall
External ID
D-0033-2026
Action Date
2025-10-29
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot # PY925014, PY925013, Exp. 1/31/2028
Quantity Affected: 13,440 bottles
Reason for Recall
Tablet/Capsules Imprinted with Wrong ID
Distribution
U.S. Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-12
Company
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 58 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
JB Chemicals and Pharmaceuticals Ltd has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (JB Chemicals and Pharmaceuticals Ltd) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does JB Chemicals and Pharmaceuticals Ltd have FDA actions?
JB Chemicals and Pharmaceuticals Ltd has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0033-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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