Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann Arbor, MI 48108, NDC 72426-818-03

FDA recall notice · announced September 13, 2023 · Esperion

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

The 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

Notes

Distribution: Nationwide USA
Lot/code information: Lot# 1904872, Exp 1/31/2025; 1950377, Exp 6/30/2025
Quantity: 45,240 bottles
Status: Completed
Products in this recall event:
- Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann Arbor, MI 48108, NDC 72426-818-03 (D-1143-2023)

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