FDAFDA · Food and drugs·Recall number D-0441-2024
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
Published April 24, 2024 · Recall initiated: March 27, 2024
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- NEXLIZET
- Manufacturer
- Esperion
- Distributor
- Nationwide in the USA
- Lot
- Lot #, 1990305, Exp 08-31-2025
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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