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

FDA recall notice · announced April 24, 2024 · Esperion

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot #, 1990305, Exp 08-31-2025
Quantity: 3,480 30-count bottles
Status: Completed
Products in this recall event:
- 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 (D-0441-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.