Prescription Drug Recall: Nexlizet Tablets Failed Dissolution Specifications
Esperion is recalling Nexlizet (bempedoic acid and ezetimibe) tablets nationwide due to failed dissolution specifications identified during stability testing. Approximately 45,240 bottles are affected.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, injuries, or deaths. The hazard is a quality/dissolution issue discovered through stability testing, which is typical of precautionary recalls and falls within the Class III classification range of 1–2.
Plain-English summary
Esperion Therapeutics is recalling Nexlizet (bempedoic acid and ezetimibe) 180mg/18mg tablets nationally. Approximately 45,240 bottles distributed nationwide are affected, including lot 1904872 (expiration 1/31/2025) and lot 1950377 (expiration 6/30/2025).
The recall was initiated due to failed dissolution specifications identified during 12-month stability testing. Affected tablets showed results below specification standards.
Patients currently taking Nexlizet from the affected lots should contact their healthcare provider or pharmacist to determine if their medication is affected and to discuss next steps. Consumers should not discontinue use of their medication without consulting their healthcare provider.
The recalled product
- Product
- NEXLIZET (BEMPEDOIC ACID AND EZETIMIBE)
- Brand
- NEXLIZET
- Manufacturer
- Esperion
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 45,240
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 (4)
- Lot# 1904872
- Exp 1/31/2025
- 1950377
- Exp 6/30/2025
Distribution
Distributed nationwide across the United States.
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