Exact FDA event identifier

Event 92950

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: August 25, 2023
Product types: Drug
Classifications: Class I and Class II
Statuses: Terminated
Recalling firm wording: Marlex Pharmaceuticals, 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

2 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 2

Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC# 10135-0747-01

D-1169-2023

Recall number: D-1169-2023
Initiated: August 25, 2023
Classification: Class I
Status: Terminated
Recalling firm: Marlex Pharmaceuticals, Inc.
Quantity: 94/100 count bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Label Mix-Up

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.

Code information

Lot # E3810, expiration date 02/2025

Distribution pattern

Nationwide in the US.

drug · product 2 of 2

Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC 10135-0748-01

D-1170-2023

Recall number: D-1170-2023
Initiated: August 25, 2023
Classification: Class II
Status: Terminated
Recalling firm: Marlex Pharmaceuticals, Inc.
Quantity: 94/100 count bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Label Mix-Up

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.

Code information

E3811, expiration date 02/2025

Distribution pattern

Nationwide in the US.