Recall

Serious risk

Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique…

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.

Official FDA data record

What to do

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  1. 1Compare the product, size and lot or date code with this notice.
  2. 2If your product matches, stop using it and follow the official recall instructions.
  3. 3Read the official notice for return, refund or disposal instructions.

What the notice says

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.

Recall details

Firm
JB Chemicals and Pharmaceuticals Ltd
Status
Ongoing
Reported
Oct 29, 2025
Started
Sep 12, 2025
Where sold
Nationwide in the USA
Quantity
34,020 100-count bottles.
Notice number
D-0732-2026

Lots, UPC, dates

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

Agency wording

Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, 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 16571-402-10.

Source: FDA OTC report. This is not medical advice. Compare your package codes before you act.