Class IIIOngoing

Cetirizine Hydrochloride Tablets USP 10 mg recall

FDA recall D-0032-2026 · initiated Sep 12, 2025

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

Why it was recalled

Tablet/Capsules Imprinted with Wrong ID

Details

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.
Recalling company: JB Chemicals and Pharmaceuticals Ltd
Classification: Class III
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: U.S. Nationwide
Initiated: Sep 12, 2025
FDA report date: Oct 29, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0032-2026 ↗

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