CLASS I Drug recall · Reported 13 Sep 2023 · FDA Enforcement Report
Digoxin Tablets, USP 0.125mg recalled by Marlex Pharmaceuticals
Marlex Pharmaceuticals is recalling Digoxin Tablets, USP 0.125mg, distributed nationwide in the US. The recall was initiated on 25 Aug 2023 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1169-2023
- FDA event ID
- 92950
- Recalling firm
- Marlex Pharmaceuticals, New Castle, DE
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 25 Aug 2023
- FDA classified
- 18 Sep 2023
- Reported
- 13 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 25 Aug 2023 | Recall initiated by company | |
| 13 Sep 2023 | Published in enforcement report | +19 days |
| 18 Sep 2023 | Classified by FDA | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC# 10135-0747-01
Where it was distributed
Nationwide in the US.
Questions about this recall
Why was it 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.
Which lots are affected?
Lot # E3810, expiration date 02/2025
Where was it sold?
Nationwide in the US.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 92950This product is part of a recall event; the main page for the event is Digoxin Tablets, USP 0.25mg recalled by Marlex Pharmaceuticals.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Digoxin Tablets, USP 0.25mg recalled by Marlex Pharmaceuticals | Marlex Pharmaceuticals | Packaging Defects | Nationwide |
More recalls from Marlex Pharmaceuticals
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Digoxin Tablets, USP 0.25mg recalled by Marlex Pharmaceuticals | Marlex Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Acetaminophen Tablets, 500 mg recalled by Marlex Pharmaceuticals | Marlex Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
Other Digoxin recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Digoxin Tablets, USP 62.5 mcg (0.0625 mg) recalled by Novitium PharmaDigoxin | Novitium Pharma | Potency & Assay | Nationwide |
| Drug | CLASS III | Digoxin Tablets, USP 125mcg, (0.125 mg) recalled by Novitium PharmaDigoxin | Novitium Pharma | Other | Nationwide |
| Drug | CLASS II | Digoxin Tablets, USP 0.25mg recalled by Marlex Pharmaceuticals | Marlex Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Digoxin, Tablet, 125 mcg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Digoxin, Tablet, 0.125 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |