Recall: D-0032-2026

Class III - Minor Violations

Class IIIClassification

2025-09-12Initiated

OngoingStatus

JB Chemicals and PharmaceuticaFirm

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.

Reason

Tablet/Capsules Imprinted with Wrong ID

Distribution

U.S. Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.