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Class II · ModerateActive recall

Enalapril Maleate

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: GEH25023, Expires: 6/30/2027
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byUnique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816 foreign manufacturer
Brand nameENALAPRIL MALEATE
Generic nameENALAPRIL MALEATE
Active ingredient(s)ENALAPRIL MALEATE
Distributed by / forRising Pharma Holdings, Inc., East Brunswick, NJ 08816
NDC64980-688-10
Show the full FDA record
Full product labelEnalapril 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 firmJB Chemicals and Pharmaceuticals Ltd
DistributionNationwide in the USA
Quantity675 bottles
Recall initiated2026-04-23
Report date2026-05-13
Recall completed—
Recall numberD-0520-2026
ClassificationClass II
FDA statusOngoing
Origin on fileMumbai India

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.