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Drug FDA Class II Ongoing Failed specifications

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.

JB Chemicals and Pharmaceuticals Ltd Published May 13, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact JB Chemicals and Pharmaceuticals Ltd or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Failed Organic Impurities Specification · primary

Affected products (1)

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.

ENALAPRIL MALEATE · 675 bottles

NDC: 64980-685, 64980-686, 64980-687, 64980-688, 64980-685-01, 64980-685-10, 64980-686-01, 64980-686-10, 64980-687-01, 64980-687-10, 64980-688-01, 64980-688-10
Code info: Lot #: GEH25023, Expires: 6/30/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Apr 23, 2026
  2. Published
    May 13, 2026
Recall number
D-0520-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.