Class IIICompleted

NEXLIZET (bempedoic acid and ezetimibe) tablets recall

FDA recall D-0441-2024 · initiated Mar 27, 2024

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

Why it was recalled

Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.

Details

Product: 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
Recalling company: Esperion
Classification: Class III
Status: Completed
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA
Initiated: Mar 27, 2024
FDA report date: Apr 24, 2024

This recall is linked to a product we cover: Nexlizet →

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0441-2024 ↗

← All drug recalls