The Recall Desk

FDA (Drugs) recall action 92950

Marlex Pharmaceuticals, Inc. recalled 2 products on 2023-09-13

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2023-09-13
Critical
0
Units
—

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • SevereFDA (Drugs)··2023-09-13

    Digoxin Tablets Nationwide Recall: Bottles Mislabeled with Incorrect Dosages

    Marlex Pharmaceuticals recalls Digoxin Tablets nationwide due to a labeling error where bottles are mislabeled with incorrect dosages. Bottles labeled as 0.125mg contain 0.25mg and vice versa.

    Product
    Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC# 10135-0747-01
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-09-13

    Digoxin Tablets Recalled Due to Reversed Dosage Labeling

    Marlex Pharmaceuticals is recalling Digoxin Tablets because bottles labeled as 0.125mg contain 0.25mg strength, and vice versa. Approximately 94 100-count bottles distributed nationwide are affected.

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