D-1143-2023 Class III Terminated
FDA drug recall D-1143-2023 was initiated by Esperion on Aug 16, 2023 and is designated Class III. Reason for recall: Failed dissolution specifications: below specification results at stability 12-month The recall status is terminated (terminated Aug 31, 2026). Affected quantity: 45,240 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Sep 13, 2023
- Initiation Date
- Aug 16, 2023
- Termination Date
- Aug 31, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45,240 bottles
Product description
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
Distribution pattern
Nationwide USA
Code information
Lot# 1904872, Exp 1/31/2025; 1950377, Exp 6/30/2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1143-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026