Jb Chemicals And Pharmaceuticals Ltd: Cetirizine Hydrochloride Tablets Usp 5 Mg, 100-count Bottle
Recall Summary Unique Pharmaceutical Laboratories is recalling four lots of Cetirizine Hydrochloride Tablets USP 5 mg (an allergy medication) because they may be contaminated with Ranitidine, a different medication used to treat acid reflux. The recall affects all consumers who purchased this product, and the company is voluntarily removing it from the market due to the cross-contamination issue.
- Recalling firm
- JB Chemicals and Pharmaceuticals Ltd
- Product
- 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
- 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.
- Classification
- Class I
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-06-24
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide in the USA
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/414ed670-6a2e-46f2-ab0e-5119812f5c83