United StatesCetirizine Hydrochloride Tablets USP 5 mg, 100‑count bottles (NDC 16571-401-10) manufactured by Unique Pharmaceuticals Labs (a division of J.B. Chemicals & Pharmaceuticals Ltd.) and distributed by Rising Pharma Holdings, lots GY825029–GY825032, exp. 2028‑OCT, sold nationwide in the U.S., are being recalled. The recall follows customer complaints of discolored tablets and red dots, with testing indicating cross‑contamination by ranitidine.
What's being recalled
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.
Recalling firm: JB Chemicals and Pharmaceuticals Ltd, Mumbai, N/A, India.
How to identify it
Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide in the USA
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)