Exact FDA event identifier

Event 95630

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

Event summary

Timeline bucket: October 25, 2024
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Lannett Company Inc.

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

Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37

D-0112-2025

Recall number: D-0112-2025
Initiated: October 25, 2024
Classification: Class II
Status: Terminated
Recalling firm: Lannett Company Inc.
Quantity: 1608 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Failed Content Uniformity Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.

Code information

Lot: 23274856A, Exp 04/30/2025

Distribution pattern

Nationwide in the USA