Recall alert: Medication recalled over labeling error; danger of overdose

Marlex Pharmaceuticals is voluntarily recalling two lots of Digoxin that were incorrectly labeled.

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The Food and Drug Administration announced the recall of one lot of Digoxin Tablets USP, 0.125 mg, and one lot of Digoxin Tablets USP, 0.25 mg.

Bottles of Digoxin Tablets, USP 0.125 mg are incorrectly labeled and contain Digoxin Tablets USP, 0.25 mg Tablets. Bottles of Digoxin Tablets USP, 0.25 mg are incorrectly labeled and contain Digoxin Tablets USP, 0.125 mg.

The mix-up in labels can cause either overdosing or underdosing in patients who unknowingly take the wrong dose, the FDA said.

Digoxin Tablets USP, 0.125 mg are yellow, circular, beveled, uncoated tablets that are scored between “N” and “201″ on one side and plain on the other side.

Digoxin Tablets USP, 0.25 mg are white to off-white, circular, beveled, uncoated tablets that are scored between “N” and “202″ on one side and plain on the other side.

Digoxin is used for the treatment of mild to moderate heart failure in children and adults.

If patients accidentally overdose, they can experience significant drug toxicity: mental disorientation, dizziness, blurred vision, memory loss and fainting.

Patients who underdose may have a loss of control of heart rate and potential heart failure exacerbation, according to the company.

According to Marlex Pharmaceuticals, no reports of adverse events related to this recall have been received.

The product is packaged as 100 tablets in white bottles and labeled as:

• Digoxin 0.125mg Tablet – NDC 10135-0747-01, lot No. E3810, expiration 2/2025.
• Digoxin 0.25mg Tablet – NDC 10135-0748-01, lot No. E3811, expiration 2/2025.

The medication was distributed nationwide.

If you have either medication, the FDA urges you to stop using the product and return it to the place where it was purchased.

Consumers with questions regarding this recall can contact Marlex Pharmaceuticals at 888-582-1953 Monday - Friday from 8:30 a.m. to 4:30 p.m. EST.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug.

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