FDA Drug recall D-1143-2023
Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann Arbor, MI 48108…
- FDA Drug
- Class III
- terminated
- Published 2023-09-13
On 2023-09-13 the FDA classified a Class III recall of Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann Arbor, MI 48108… by Esperion, citing failed dissolution specifications: below specification results at stability 12-month.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1143-2023 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2023-08-16 |
| Published | 2023-09-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Esperion |
| Distribution | US |
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
Failed dissolution specifications: below specification results at stability 12-month
Identifiers
| ndc | 72426-818-03 |
|---|---|
| ndc | 72426-818-99 |
| ndc | 72426-818-09 |
| code_info | Lot# 1904872, Exp 1/31/2025; 1950377, Exp 6/30/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1143-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.