Nexlizet Tablet, Film Coated
FDA Recall NDC 72426-818
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Nexlizet (NDC 72426-818). A significant event, classified as Class III, was initiated on Mar 27, 2024 by Esperion Therapeutics, Inc.. The reported reason for this action was: "Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint."
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Completed
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Mar 27, 2024
Apr 24, 2024
3,480 30-count bottles
Recall Profile & Regulatory Data
Event ID
94365
Classification
Class III
Enforcement Status
Completed
Recalling Firm
Esperion
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only, Manufactured for: Esperion Therapeutics, Ann Arbor, MI 48108, NDC 72426-818-03
Batch or Lot Expiration Information
Lot# 1990305, Exp 08-31-2025
Affected Packages Involved in this Recall
72426-818-03Product
72426-818-99Product
Class III Completed
Failed dissolution specifications: below specification results at stability 12-month
Aug 16, 2023
Sep 13, 2023
45,240 bottles
Recall Profile & Regulatory Data
Event ID
92897
Classification
Class III
Enforcement Status
Completed
Recalling Firm
Esperion
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Product Description
Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann Arbor, MI 48108, NDC 72426-818-03
Batch or Lot Expiration Information
Lot# 1904872, Exp 1/31/2025; 1950377, Exp 6/30/2025
Affected Packages Involved in this Recall
72426-818-03Product
72426-818-99Product
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.
