CLASS III Drug recall · Reported 24 Apr 2024 · FDA Enforcement Report
Nexlizet (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg recalled
Esperion is recalling Nexlizet (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, distributed nationwide in the US. The recall was initiated on 27 Mar 2024 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0441-2024
- FDA event ID
- 94365
- Recalling firm
- Esperion, Ann Arbor, MI
- Brand
- Nexlizet
- Manufacturer
- Esperion Therapeutics, Inc.
- Classification
- Class III
- Status
- Completed
- Recall initiated
- 27 Mar 2024
- FDA classified
- 12 Apr 2024
- Reported
- 24 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Cholesterol Medication
Timeline
| 27 Mar 2024 | Recall initiated by company | |
| 12 Apr 2024 | Classified by FDA | +16 days |
| 24 Apr 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Nexlizet (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg recalled?
Yes. Esperion recalled Nexlizet (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg on 27 Mar 2024. The recall is Class III and its status is Completed. Recall number D-0441-2024.
Why was it recalled?
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Which lots are affected?
Lot #, 1990305, Exp 08-31-2025
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Esperion
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg recalled by EsperionNexlizet | Esperion | Potency & Assay | Nationwide |
Other Bempedoic Acid recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg recalled by EsperionNexlizet | Esperion | Potency & Assay | Nationwide |