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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Nexlizet Tablets Recalled for Failed Dissolution Specifications

Agency Publication Date: April 12, 2024
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Summary

Esperion has recalled approximately 3,480 30-count bottles of Nexlizet (bempedoic acid and ezetimibe) tablets (180 mg/10 mg). The recall was issued because the medication failed bempedoic acid dissolution tests at its initial testing point, meaning the drug may not dissolve properly in the body. This could potentially reduce the medication's effectiveness in managing cholesterol levels.

Risk

The medication failed to meet dissolution specifications, which may prevent the active ingredients from being absorbed correctly by the body. No incidents or injuries have been reported to date.

What You Should Do

  1. This recall affects 30-count bottles of Nexlizet (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, with NDC 72426-818-03, Lot 1990305, and an expiration date of 08-31-2025.
  2. 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 the manufacturer for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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) tablets (30-count bottle)
Variants: 180 mg/10 mg, Rx only
Lot Numbers:
1990305 (Exp 08-31-2025)
NDC:
72426-818-03

Recall #: D-0441-2024

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94365
Status: Resolved
Manufacturer: Esperion
Sold By: Retail pharmacies
Manufactured In: United States
Units Affected: 3,480 30-count 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 ยท 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.