# FDA recall D-1143-2023

> **Esperion** · Class III · drug recall initiated 2023-08-16.

## 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

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-1143-2023
- **Recalling firm:** Esperion
- **Classification:** Class III
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2023-08-16
- **Report date:** 2023-09-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ann Arbor, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1143-2023

## Citation

> AI Analytics. FDA recall D-1143-2023. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/D-1143-2023. Source: US FDA. Licensed CC0.

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