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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94365

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 27, 2024
Product types
Drug
Classifications
Class III
Statuses
Completed
Recalling firm wording
Esperion

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-0441-2024
Recall number
D-0441-2024
Initiated
March 27, 2024
Classification
Class III
Status
Completed
Recalling firm
Esperion
Quantity
3,480 30-count bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out-of-specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.

Code information

Lot #, 1990305, Exp 08-31-2025

Distribution pattern

Nationwide in the USA