Ann Arbor, MI, United States
Esperion recalls
2 recalls recorded since 2018, most recently on 27 March 2024. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Completed Class III Drugs
- Recall started
- 27 March 2024
- Reason
- Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0441-2024
- 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
Terminated Class III Drugs
- Recall started
- 16 August 2023
- Terminated
- 31 August 2026
- Reason
- Failed dissolution specifications: below specification results at stability 12-month
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1143-2023
- Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann Arbor, MI 48108, NDC 72426-818-03
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.