NEXLIZET — Class III drug recall D-0441-2024
Completed recall by Esperion, reported 2024-04-24, distributed nationwide. Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
| Recall number | D-0441-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Esperion, Ann Arbor, MI, United States |
| Recall initiated | 2024-03-27 |
| Classified | 2024-04-12 |
| Reported by FDA | 2024-04-24 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 72426-0818, 72426-0818-03, 72426-0818-09, 72426-0818-99 |
| Lot numbers | 1990305 |
| Expiration dates | 2025-08-31 |
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 for recall
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0441-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.