FDAClass II · Drug · Recalled May 13, 2026
Enalapril Maleate Tablets recall — JB Chemicals and Pharmaceuticals Ltd
Hazard: Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
Description
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.
Affected products
Companies & origin
Identifying details (verbatim from the notice)
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.