FDAHealthSeptember 12, 2025
JB Chemicals and Pharmaceuticals Ltd — Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.)
⚠️ Tablet/Capsules Imprinted with Wrong ID
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 12, 2025
U.S. Nationwide
What's affected?
- Product
- 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
- Lot code
- PY925014
Additional details
Lot # PY925014, PY925013, Exp. 1/31/2028
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 13,440 bottles.
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