FlaggedRx← Medication recall checkHome
Class I · Most seriousActive recall

Cetirizine Hydrochloride

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byUnique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816 foreign manufacturer
Brand nameCETIRIZINE HYDROCHLORIDE
Generic nameCETIRIZINE HYDROCHLORIDE
Active ingredient(s)CETIRIZINE HYDROCHLORIDE
Distributed by / forRising Pharma Holdings, Inc., East Brunswick, NJ 08816
NDC16571-401-10
Show the full FDA record
Full product labelCetirizine 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 firmJB Chemicals and Pharmaceuticals Ltd
DistributionNationwide in the USA
Quantity34,020 100-count bottles.
Recall initiated2026-06-24
Report date2026-07-29
Recall completed—
Recall numberD-0732-2026
ClassificationClass I
FDA statusOngoing
Origin on fileMumbai N/A India

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.