Medications & Supplements/Prescription Drugs

Digoxin Tablets Recalled for Label Mix-up and Incorrect Dosage Strengths

Agency Publication Date: September 5, 2023

Summary

Marlex Pharmaceuticals, Inc. has recalled 94 bottles of Digoxin, a heart medication, because bottles labeled as 0.125 mg may contain 0.25 mg tablets, and vice-versa. Digoxin (digoxin) is used to treat heart failure and irregular heartbeats. Taking the incorrect dose could lead to significant health complications, though no incidents or injuries have been reported to date. The tablets were sold in 100-count bottles through pharmacies across the country.

Risk

Taking double the intended dose (0.25 mg instead of 0.125 mg) can lead to digoxin toxicity, causing nausea, vomiting, and potentially fatal heart rhythm issues. Conversely, taking half the intended dose (0.125 mg instead of 0.25 mg) may fail to manage heart conditions, leading to worsening heart failure or irregular heartbeats.

What You Should Do

This recall affects 100-count bottles of Marlex Digoxin Tablets, USP in 0.125 mg and 0.25 mg strengths with lot numbers E3810 or E3811 and an expiration date of February 2025.
Check your medication bottle for NDC 10135-0747-01 (for 0.125 mg tablets) or NDC 10135-0748-01 (for 0.25 mg tablets) and confirm if the lot number on the side of the label matches E3810 or E3811.
If you have health concerns or believe you have been taking an incorrect dosage, contact your healthcare provider or pharmacist immediately.
Return any unused product to the place of purchase for a refund, throw it away, or contact Marlex Pharmaceuticals, Inc. directly for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Digoxin Tablets, USP 0.125mg (100-count)

Variants: 0.125 mg, Tablet

Lot Numbers:

E3810 (Exp 02/2025)

NDC:

10135-0747-01

Bottles labeled as 0.125 mg may contain 0.25 mg tablets.

Product: Digoxin Tablets, USP 0.25mg (100-count)

Variants: 0.25 mg, Tablet

Lot Numbers:

E3811 (Exp 02/2025)

NDC:

10135-0748-01

Bottles labeled as 0.25 mg may contain 0.125 mg tablets.

Product Images

Label for Digoxin Tablets USP, 0.125mg

Label for Digoxin Tablets USP, 0.25mg

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92950

Status: Resolved

Manufacturer: Marlex Pharmaceuticals, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 2 products (94/100 count bottles)

Distributed To: Nationwide

Agency Last Updated: September 18, 2023

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

This recall affects 100-count bottles of Marlex Digoxin Tablets, USP in 0.125 mg and 0.25 mg strengths with lot numbers E3810 or E3811 and an expiration date of February 2025.

Check your medication bottle for NDC 10135-0747-01 (for 0.125 mg tablets) or NDC 10135-0748-01 (for 0.25 mg tablets) and confirm if the lot number on the side of the label matches E3810 or E3811.

If you have health concerns or believe you have been taking an incorrect dosage, contact your healthcare provider or pharmacist immediately.

Return any unused product to the place of purchase for a refund, throw it away, or contact Marlex Pharmaceuticals, Inc. directly for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Digoxin Tablets, USP 0.125mg (100-count)

Variants: 0.125 mg, Tablet

Lot Numbers:

E3810 (Exp 02/2025)

NDC:

10135-0747-01

Bottles labeled as 0.125 mg may contain 0.25 mg tablets.

Product: Digoxin Tablets, USP 0.25mg (100-count)

Variants: 0.25 mg, Tablet

Lot Numbers:

E3811 (Exp 02/2025)

NDC:

10135-0748-01

Bottles labeled as 0.25 mg may contain 0.125 mg tablets.