Marlex Pharmaceuticals recalls 0.125mg Digoxin tablets due to label mix-up with 0.25mg strength. This could lead to incorrect dosing if taken without checking labels.
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.
Marlex Pharmaceuticals is recalling 100-count Digoxin tablets labeled as 0.125mg but containing 0.25mg, and vice versa. This mix-up risks incorrect dosing if patients take the tablets without verifying the label.
The tablets are mislabeled, so patients might take a higher dose than intended. Digoxin is a critical medication for heart conditions, and incorrect dosing could cause serious health issues.
Prescription patients who have received these specific Digoxin tablets. Those with medical conditions requiring precise dosing are most at risk.
Check for bottles labeled as Digoxin Tablets, USP 0.125mg that contain 0.25mg, and vice versa. The product was sold with NDC# 10135-0747-01 and lot # E3810, expiring 02/2025.
Verify the tablet strength on the label matches the actual contents to avoid incorrect dosing.
This recall is low risk as it involves a labeling error that could lead to incorrect dosing if not checked, but does not cause immediate harm.
Look for bottles labeled as Digoxin Tablets, USP 0.125mg containing 0.25mg or vice versa, with NDC# 10135-0747-01 and lot # E3810, expiring 02/2025.
Check the label to confirm the tablet strength. If unsure, contact your doctor or pharmacist for guidance.
We’ve drafted a message you can send Marlex Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-1169-2023 — Marlex Pharmaceuticals Marlex Pharmaceuticals Hello, I own a Marlex Pharmaceuticals that is covered by recall D-1169-2023 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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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.
