Prescription drug NEXLIZET recalled for dissolution specification failure
Esperion is recalling certain NEXLIZET (bempedoic acid and ezetimibe) tablets nationwide because the active ingredient may not dissolve properly, potentially reducing effectiveness.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. The defect is a pharmaceutical manufacturing quality issue (failed dissolution), but Class III recalls with no reported harm are typically rated as Moderate.
Plain-English summary
Esperion Therapeutics is recalling 3,480 bottles of NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, due to out-of-specification bempedoic acid dissolution at the 0-month timepoint. The defect means the active ingredient may not dissolve properly in the body, which could affect the drug's effectiveness in lowering cholesterol.
The affected product is NEXLIZET in 30-count bottles with lot number 1990305 (expiration date 08-31-2025). The product was distributed nationwide.
If you are taking NEXLIZET and have concerns about your medication, consult your healthcare provider or pharmacist. Do not stop taking your medication without speaking to your doctor. For questions about this recall, contact Esperion or the FDA.
The recalled product
- Product
- NEXLIZET (BEMPEDOIC ACID AND EZETIMIBE)
- Brand
- NEXLIZET
- Manufacturer
- Esperion
- Category
- Drug — Prescription Tablet
- Hazard
- dissolution-failure
- efficacy-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #
- 1990305
- Exp 08-31-2025
Distribution
Distributed nationwide across the United States.
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