Class III · Low risk
Ezetimibe and Simvastatin Tablets
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
NEXLIZET (bempedoic acid and ezetimibe)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
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
Affected NDC
72426-0818-03
Compare with the code on your package — it is the most precise check available.
Drug: Ezetimibe Category: Cholesterol Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Nexlizet Bempedoic Acid and Ezetimibe NDC 72426-0818 |
BEMPEDOIC ACID 180 mg/1; EZETIMIBE 10 mg/1 | Tablet, Film Coated Oral |
Esperion Therapeutics, Inc. | Rx |
- Recalling firm
- Esperion
- NDC code
- 72426-818-03
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0441-2024 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now completed, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Ezetimibe recalls
See all
Class III · Low risk
Nexlizet (bempedoic acid and ezetimibe)
Failed dissolution specifications: below specification results at stability 12-month
Class II · Moderate risk
Ezetimibe and Simvastatin Tablets
Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity
Class II · Moderate risk
Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Class II · Moderate risk
Dr. Reddy's Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Other recalls by Esperion
All 2024 recalls
Class III · Low risk
Nexlizet (bempedoic acid and ezetimibe)
Failed dissolution specifications: below specification results at stability 12-month
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