Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.
Summary
The FDA issued a Class I for Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Un by JB Chemicals and Pharmaceuticals Ltd. Reason: Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride T.
Details
Source
Drug Recall
External ID
D-0732-2026
Action Date
2026-07-29
Status
Ongoing
Category
drug
Product Description
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.
Lot/Code Info: Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT
Quantity Affected: 34,020 100-count bottles.
Reason for Recall
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.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-24
Company
Mumbai, N/A
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 45 drug recalls issued in the same week, part of 63 drug-related FDA actions this month.
JB Chemicals and Pharmaceuticals Ltd has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0732-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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