United StatesEnalapril Maleate Tablets, USP 20 mg, 1,000-count bottle (Rx only), NDC 64980-688-10, Lot GEH25023, expires 6/30/2027, manufactured by Unique Pharmaceutical Laboratories (J.B. Chemicals & Pharmaceuticals Ltd.) and distributed by Rising Pharma Holdings, are being recalled nationwide in the USA (675 bottles). The recall was initiated because an out-of-specification result occurred in the Organic Impurities Test, indicating failed impurities/degradation specifications.
What's being recalled
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.
Recalling firm: JB Chemicals and Pharmaceuticals Ltd, Mumbai, India.
How to identify it
Lot #: GEH25023, Expires: 6/30/2027
The hazard
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide in the USA
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)