US Drug Recall Register
Class II · Moderate risk Terminated Initiated Aug 25, 2023 (3 years ago)

Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was 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.

What was recalled

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

Recalling firm
Marlex Pharmaceuticals, Inc.
NDC code
10135-0748-01
Origin
DE, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1170-2023

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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