Exact FDA event identifier

Event 92897

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

Event summary

Timeline bucket: August 16, 2023
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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann Arbor, MI 48108, NDC 72426-818-03

D-1143-2023

Recall number: D-1143-2023
Initiated: August 16, 2023
Classification: Class III
Status: Completed
Recalling firm: Esperion
Quantity: 45,240 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Failed dissolution specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed dissolution specifications: below specification results at stability 12-month

Code information

Lot# 1904872, Exp 1/31/2025; 1950377, Exp 6/30/2025

Distribution pattern

Nationwide USA