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,...
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Quick Facts at a Glance
- Recall Date
- April 23, 2026
- Hazard Level
- HIGH
- Brands
- ENALAPRIL MALEATE, Rising Pharma Holdings, Inc.
- Geographic Scope
- 1 states
Hazard Information
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact JB Chemicals and Pharmaceuticals Ltd or your healthcare provider for guidance. Notification method: Letter
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Full 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.. Generic: ENALAPRIL MALEATE; Brand: ENALAPRIL MALEATE. Reason: Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test. Classification: Class II. Quantity: 675 bottles. Distribution: Nationwide in the USA
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