Recall: D-0520-2026

Class II - Potentially Harmful

Class IIClassification

2026-04-23Initiated

OngoingStatus

JB Chemicals and PharmaceuticaFirm

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

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.