Digoxin Tablets Nationwide Recall: Bottles Mislabeled with Incorrect Dosages
Marlex Pharmaceuticals recalls Digoxin Tablets nationwide due to a labeling error where bottles are mislabeled with incorrect dosages. Bottles labeled as 0.125mg contain 0.25mg and vice versa.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is FDA Class I, which mandates a minimum severity rating of Severe. No illnesses or injuries have been reported in the source material, preventing a Critical classification.
Plain-English summary
Marlex Pharmaceuticals, Inc. has recalled Digoxin Tablets, USP, distributed in 100-count bottles, due to a labeling mix-up. Bottles labeled as containing Digoxin Tablets, USP 0.125 mg actually contain 0.25mg, and bottles labeled as 0.25mg actually contain 0.125mg. The affected lot number is E3810 with an expiration date of February 2025, distributed nationwide in the United States.
Digoxin is a cardiac medication used to treat heart conditions. It has a narrow therapeutic window, meaning that even small deviations from the prescribed dose can result in serious health effects. Patients receiving the incorrect dose face risk of medication toxicity from overdose or loss of therapeutic benefit from underdose.
The recall affects patients who obtained Digoxin Tablets from lot E3810 through pharmacies or healthcare providers. Approximately 94 bottles of the 100-count size were affected.
Patients taking Digoxin Tablets should verify the lot number on their bottles. If the medication is from lot E3810, they should contact their healthcare provider or pharmacist immediately for guidance.
The recalled product
- Product
- Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC# 10135-0747-01
- Manufacturer
- Marlex Pharmaceuticals, Inc.
- Category
- Drug
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # E3810
- expiration date 02/2025
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Marlex Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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