D-0732-2026 Class I Ongoing
FDA drug recall D-0732-2026 was initiated by JB Chemicals and Pharmaceuticals Ltd on June 24, 2026 and is designated Class I. 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. The recall status is ongoing. Affected quantity: 34,020 100-count bottles..
Recall Details
- Product Type
- Drugs
- Report Date
- July 29, 2026
- Initiation Date
- June 24, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34,020 100-count bottles.
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.
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 Pattern
Nationwide in the USA
Code Information
Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT