Enalapril Maleate Tablet
FDA Recall NDC 64980-686
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Enalapril Maleate (NDC 64980-686). A significant event, classified as Class II, was initiated on Apr 23, 2026 by Rising Pharma Holdings, Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Apr 23, 2026
May 13, 2026
675 bottles
Recall Profile & Regulatory Data
Event ID
98794
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
JB Chemicals and Pharmaceuticals Ltd
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product 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.
Batch or Lot Expiration Information
Lot# : GEH25023, Expires: 6/30/2027
Affected Packages Involved in this Recall
64980-685-01Product
64980-685-10Product
64980-686-01Product
64980-686-10Product
64980-687-01Product
64980-687-10Product
64980-688-01Product
64980-688-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
