HIGHFDA DRUG

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

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
April 23, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
April 23, 2026
Hazard Level
HIGH
Brands
ENALAPRIL MALEATE, Rising Pharma Holdings, Inc.
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
ENALAPRIL MALEATE, Rising Pharma Holdings, Inc.
Model numbers
Lot #: GEH25023, Expires: 6/30/2027
UPC codes
64980-685, 64980-686, 64980-687, 64980-688, 64980-685-01, 64980-685-10, 64980-686-01, 64980-686-10 +4 more
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    April 23, 2026

  2. Reported by FDA DRUG

    May 13, 2026

  3. RecallRadar source check

    May 20, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

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

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
Lot #: GEH25023
Expires: 6/30/2027
UPC Codes
64980-685
64980-686
64980-687
+9 more
Affected States
ALL
Report Date
May 13, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE