Esperion

FDA Regulatory Profile

Esperion appears in FDA public data with 2 recalls, 0 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0441-2024, Class III) was initiated on March 27, 2024.

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0441-2024Class IIINEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only, ManufactureMarch 27, 2024
D-1143-2023Class IIINexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: EsperionAugust 16, 2023