Esperion recalls NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only, Manufactured for: Esperion The…

Recall date

March 27, 2024

Source

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

Recall number

D-0441-2024

FDA classification

Class III

Brand / firm

Esperion

Sold / distributed

Nationwide in the USA

Why it was recalled

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

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

What was recalled

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