NEXLIZET (bempedoic acid and ezetimibe) tablets recall
FDA recall D-0441-2024 · initiated Mar 27, 2024
Esperion recalled NEXLIZET (bempedoic acid and ezetimibe) tablets in Mar 2024 — an FDA Class III recall (D-0441-2024) because Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
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.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 3,480 30-count bottles
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 →
Frequently asked
- Was NEXLIZET (bempedoic acid and ezetimibe) tablets recalled?
- Esperion recalled NEXLIZET (bempedoic acid and ezetimibe) tablets in Mar 2024 — an FDA Class III recall (D-0441-2024) because Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was NEXLIZET (bempedoic acid and ezetimibe) tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0441-2024 was: Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
- Is a recalled NEXLIZET (bempedoic acid and ezetimibe) tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of NEXLIZET (bempedoic acid and ezetimibe) tablets are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #, 1990305, Exp 08-31-2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0441-2024.