FDA recall D-0520-2026

JB Chemicals and Pharmaceuticals Ltd · Class II · drug

Product

Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 64980-688-10.

Reason for recall

Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test

Distribution

Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2026-04-23
Report date
2026-05-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mumbai, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0520-2026