Recall
FDAHealthSeptember 12, 2025

JB Chemicals and Pharmaceuticals Ltd — Cetirizine Hydrochloride Tablets USP 10 mg, 100 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, 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.
Lot code
PY925014A

Additional details

Lot # PY925014A; Exp. 1/31/2028

What should I do?

Recommended action

Class III recall. Voluntary: Firm initiated Quantity affected: 9936 bottles.

View original FDA notice →

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