FDA Drug recall D-0441-2024
NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only, Manufactured for: Esperion Therapeutics, Ann Arbor…
- FDA Drug
- Class III
- completed
- Published 2024-04-24
On 2024-04-24 the FDA classified a Class III recall of NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only, Manufactured for: Esperion Therapeutics, Ann Arbor… by Esperion, citing failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0441-2024 |
| Classification | Class III |
| Status | completed |
| Initiated | 2024-03-27 |
| Published | 2024-04-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Esperion |
| Distribution | US |
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
Reason
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Identifiers
| ndc | 72426-818-03 |
|---|---|
| ndc | 72426-818-99 |
| ndc | 72426-818-09 |
| code_info | Lot #, 1990305, Exp 08-31-2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0441-2024%22
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