FDA recall D-0033-2026

JB Chemicals and Pharmaceuticals Ltd · Class III · drug

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

Reason for recall

Tablet/Capsules Imprinted with Wrong ID

Distribution

U.S. Nationwide

Key facts

Status: Ongoing
Initiation date: 2025-09-12
Report date: 2025-10-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mumbai, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0033-2026