FDAFDA · Food and drugs·Recall number D-0033-2026
Cetirizine Hydrochloride Tablets USP 10 mg, 500 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 16571-402-50
Published October 29, 2025 · Recall initiated: September 12, 2025
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
Tablet/Capsules Imprinted with Wrong ID
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CETIRIZINE HYDROCHLORIDE
- Manufacturer
- JB Chemicals and Pharmaceuticals Ltd
- Distributor
- U.S. Nationwide
- Lot
- Lot # PY925014, PY925013, Exp. 1/31/2028
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- India
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