Marlex Pharmaceuticals, Inc. recalls Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc.
Marlex Pharmaceuticals recalls 0.25mg Digoxin tablets due to label mix-ups with 0.125mg strength. Consumers may have incorrect dosing.
Lower-risk 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.
Contact the company & request your remedy
What happened, in plain English
Marlex Pharmaceuticals is recalling 0.25mg Digoxin tablets because some bottles are labeled incorrectly as 0.125mg when they contain 0.25mg. This could lead to incorrect dosing if taken without checking the label. Read more at govinfonow.com/recall/33163-marlex-digoxin-tablets-0-25mg-recall-label-mix-up-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/33163-marlex-digoxin-tablets-0-25mg-recall-label-mix-up-risk · Updated September 23, 2026 · FDA enforcement record: FDA #D-1170-2023
Cite this page
“Marlex Digoxin Tablets 0.25mg Recall: Label Mix-Up Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/33163-marlex-digoxin-tablets-0-25mg-recall-label-mix-up-risk. Based on FDA recall #D-1170-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1170-2023%22&limit=1).
Why it’s dangerous
The label mix-up means bottles intended for 0.125mg strength are labeled as 0.25mg, and vice versa. This could cause incorrect dosing if the label is not checked before use.
Who’s affected
Prescription holders of Digoxin tablets who received bottles labeled as 0.125mg but contain 0.25mg. Those with specific medical conditions requiring precise dosing are at higher risk.
How to tell if you have this one
Check the label on the bottle for the strength: 0.125mg or 0.25mg. The product is a 100-count bottle with NDC 10135-0748-01, manufactured by Marlex Pharmaceuticals.
- Brand
Marlex Pharmaceuticals- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Status
Terminated- Distribution
Nationwide in the US.
| Recall number | Product, codes & lots | Class |
|---|---|---|
| D-1169-2023 | Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC# 10135-0747-01; Lot # E3810, expiration date 02/2025 | Class I |
| D-1170-2023 | Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC 10135-0748-01; E3811, expiration date 02/2025 | Class II |
What to do — step by step
Check Label Carefully
Verify the tablet strength on the label before use to ensure it matches the intended dose.
Questions people ask
Are these tablets dangerous if taken without checking the label?
The recall is due to label mix-ups, not an immediate safety hazard. Correct dosing is critical, so checking the label is important.
How can I tell if I have the recalled product?
Look for bottles labeled as 0.125mg containing 0.25mg or vice versa. The product is a 100-count bottle with NDC 10135-0748-01.
Do I need to stop using these tablets?
No, but you should check the label before each use to ensure you have the correct strength.
Contact Marlex Pharmaceuticals
We’ve drafted a message you can send Marlex Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-1170-2023 — Marlex Pharmaceuticals Marlex Pharmaceuticals Hello, I own a Marlex Pharmaceuticals that is covered by recall D-1170-2023 from Marlex Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1170-2023 (August 25, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1170-2023 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.