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) ↗

Official recall ID: D-0520-2026
Brand: JB Chemicals and Pharmaceuticals
Classification: Class II
Units affected: 675 bottles
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

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

Enalapril Maleate Tablets

Companies & origin

Recalling firm location: Mumbai, India
Firm address: Neelam Centre A Wing A B Wing, 4th Floor; Hind Cycle Road, N/A

Identifying details (verbatim from the notice)

Product codes / lots: Lot #: GEH25023, Expires: 6/30/2027
Distribution: Nationwide in the USA
Firm notified the public via: Letter
FDA event ID: 98794
Recall initiated: April 23, 2026
FDA classified: May 5, 2026
FDA report date: May 13, 2026

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 24, 2026 at 12:00 AM UTC.

Report a data error on this page