FDAHealthJune 24, 2026

JB Chemicals and Pharmaceuticals Ltd — Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mu

⚠️ 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.

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: June 24, 2026

Nationwide in the USA

What's affected?

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.
Brand: CETIRIZINE HYDROCHLORIDE
Lot code: GY825029

Additional details

Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT

What should I do?

Recommended action

Class I recall. Voluntary: Firm initiated Quantity affected: 34,020 100-count bottles..

View original FDA notice →

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