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SeriousFDAOngoing

Can cause serious harm or death. Speak to your pharmacist or doctor before taking it — do not stop a prescribed medicine on your own.

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.

Check the label for

Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT
Why
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.
Distributed
Nationwide in the USA
Company
JB Chemicals and Pharmaceuticals Ltd
Announced
This is the date the recall was announced. A company may have started it weeks earlier.
Recall began

Already ate or took it and feel unwell? Call Poison Control — 1-800-222-1222

Source: FDA record D-0732-2026 · retrieved 3 August 2026

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