Esperion recalls Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc,…

Recall date

August 16, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1143-2023

FDA classification

Class III

Brand / firm

Esperion

Sold / distributed

Nationwide USA

Why it was recalled

Failed dissolution specifications: below specification results at stability 12-month

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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