Digoxin Tablets Recalled Due to Reversed Dosage Labeling
Marlex Pharmaceuticals is recalling Digoxin Tablets because bottles labeled as 0.125mg contain 0.25mg strength, and vice versa. Approximately 94 100-count bottles distributed nationwide are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a labeling mix-up on a prescription medication with no reported illnesses or injuries. It meets the criterion for High severity as a risk-of-harm product (cardiac medication with critical dosage requirements) where injury has not yet been reported.
Plain-English summary
Marlex Pharmaceuticals, Inc. is recalling Digoxin Tablets due to a labeling error. Bottles labeled as containing Digoxin Tablets, USP 0.125mg actually contain Digoxin Tablets, USP 0.25mg, and bottles labeled as containing 0.25mg actually contain 0.125mg. The affected product is in 100-count bottles (NDC 10135-0748-01) with lot code E3811 and expiration date 02/2025.
This labeling mix-up means patients may take an incorrect dose of their medication. Digoxin is a prescription cardiac medication, and dosage accuracy is critical for safe use.
Approximately 94 100-count bottles were distributed nationwide. Patients currently taking Digoxin should contact their pharmacist or healthcare provider immediately to verify they have the correct strength. Those with recalled product should not take the medication until the error is confirmed and corrected. Return the recalled bottles to the pharmacy for replacement with the correctly labeled product.
The recalled product
- Product
- Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC 10135-0748-01
- Manufacturer
- Marlex Pharmaceuticals, Inc.
- Category
- Drug
- Hazard
- mis-labeling
- incorrect-dosage
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)
- E3811
- expiration date 02/2025
Distribution
Distributed nationwide across the United States.
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