Nexlizet — Class III drug recall D-1143-2023
Terminated recall by Esperion, reported 2023-09-13, distributed nationwide. Failed dissolution specifications: below specification results at stability 12-month
| Recall number | D-1143-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Esperion, Ann Arbor, MI, United States |
| Recall initiated | 2023-08-16 |
| Classified | 2023-09-06 |
| Reported by FDA | 2023-09-13 |
| Terminated | 2026-08-31 |
| Distributed | Nationwide (US) |
| Quantity | 45,240 bottles |
| Reason classes | specification failure |
| NDC | 72426-0818, 72426-0818-03, 72426-0818-09, 72426-0818-99 |
| Lot numbers | 1904872, 1950377 |
| Expiration dates | 2025-01-31, 2025-06-30 |
Product
Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann Arbor, MI 48108, NDC 72426-818-03
Reason for recall
Failed dissolution specifications: below specification results at stability 12-month
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-1143-2023. 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.