Cetirizine Hydrochloride Tablets USP 5 mg…

Date

July 29, 2026

Risk class

Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)

Status

Ongoing

Filed by

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.

Distribution pattern

Nationwide in the USA

Quantity

34,020 100-count bottles.

Codes and lots

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

Recall started

June 24, 2026

Recall number

D-0732-2026

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0732-2026. The agency record governs; check it and the company before acting.