FDAFDA · Food and drugs·Recall number D-0732-2026
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.
Published July 29, 2026 · Recall initiated: June 24, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CETIRIZINE HYDROCHLORIDE
- Manufacturer
- JB Chemicals and Pharmaceuticals Ltd
- Distributor
- Nationwide in the USA
- Lot
- Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- India
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