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JB Chemicals and Pharmaceuticals Ltd: Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chem

DrugsSource: FDA (drug) · Date: 2026-05-13

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
JB Chemicals and Pharmaceuticals Ltd
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 / hazard
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide in the USA
Recall initiated
2026-04-23
Code info
Lot #: GEH25023, Expires: 6/30/2027
Product quantity
675 bottles
Voluntary mandated
Voluntary: Firm initiated
City
Mumbai
Country
India
Event id
98794
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