Medications & Supplements/Prescription Drugs

Nexlizet (bempedoic acid and ezetimibe) Recalled for Dissolution Failure

Agency Publication Date: September 6, 2023

Summary

Esperion Therapeutics is recalling 45,240 bottles of Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg tablets. This recall was issued because the medication failed dissolution testing, meaning the tablets did not dissolve at the expected rate during a 12-month quality check. No incidents or injuries have been reported in connection with this issue.

Risk

If the medication does not dissolve properly in the body, it may not be absorbed as intended, which could potentially reduce the effectiveness of the drug in treating its intended condition.

What You Should Do

This recall affects Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30-count bottles of tablets sold under NDC 72426-818-03.
Check your medication bottle for lot number 1904872 with an expiration date of 1/31/2025, or lot number 1950377 with an expiration date of 6/30/2025.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Esperion for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Nexlizet (bempedoic acid and ezetimibe) (30 tablets)

Variants: 180ng/18mg, Tablet

Lot Numbers:

1904872 (Exp 1/31/2025)

1950377 (Exp 6/30/2025)

NDC:

72426-818-03

Recall #: D-1143-2023

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92897

Status: Resolved

Manufacturer: Esperion

Sold By: Pharmacies; Healthcare Providers

Manufactured In: United States

Units Affected: 45,240 bottles

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30-count bottles of tablets sold under NDC 72426-818-03.

Check your medication bottle for lot number 1904872 with an expiration date of 1/31/2025, or lot number 1950377 with an expiration date of 6/30/2025.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Esperion for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional information.