FDAClass IIISeptember 13, 2023

Nexlizet recall: Failed Dissolution

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

Why was Nexlizet recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot# 1904872, Exp 1/31/2025; 1950377, Exp 6/30/2025

Product
Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann Arbor, MI 48108, NDC…
Recalling firm
Esperion
Quantity
45,240 bottles
Distribution
Nationwide USA
Recall date
September 13, 2023
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls