# FDA recall D-0441-2024

> **Esperion** · Class III · drug recall initiated 2024-03-27.

## Product

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

## Reason for recall

Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0441-2024
- **Recalling firm:** Esperion
- **Classification:** Class III
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2024-03-27
- **Report date:** 2024-04-24

- **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-0441-2024

## Citation

> AI Analytics. FDA recall D-0441-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0441-2024. Source: US FDA. Licensed CC0.

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