FDA recall D-0732-2026

JB Chemicals and Pharmaceuticals Ltd · Class I · drug

Product

Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, 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 16571-401-10.

Reason for recall

Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.

Distribution

Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2026-06-24
Report date
2026-07-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mumbai, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0732-2026