Recall archive / FDA company announcement
Marlex Pharmaceuticals, Inc.: Digoxin Tablets USP, 0.125mg and 0.25mg — FDA announcement Aug 31, 2023
Reported terminated
A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.
Source date Aug 31, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Digoxin Tablets USP, 0.125mg and 0.25mg
- Reason
- Label Mix-Up
- Classification
- Not supplied
- Recalling firm
- Marlex Pharmaceuticals, Inc.
- Quantity
- Not supplied
- Agency-reported status
- Terminated in FDA listing
- Source record identifier
- 28eedcea963f31a0
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | FOR IMMEDIATE RELEASE – August 30, 2023 – New Castle, Delaware, Marlex Pharmaceuticals, Inc. is voluntarily recalling one lot of Digoxin Tablets USP, 0.125mg and one lot of Digoxin Tablets USP, 0.25mg to the consumer level due to Label Mix-Up. Bottles of Digoxin Tablets, USP 0.125mg s are incorrectly labeled and contain Digoxin Tablets USP, 0.25mg Tablets. Bottles of Digoxin Tablets USP, 0.25mg are incorrectly labeled and contain Digoxin Tablets USP, 0.125mg.; The product is used for the treatment of mild to moderate heart failure. Digoxin increases heart muscle contraction in pediatric patients with heart failure. Digoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. The product is packaged as 100 tablets in white HDPE bottles and labeled as indicated below with NDC, lot and expiration date.; Digoxin 0.125mg Tablet – NDC 10135-0747-01, lot# E3810, expiration 2/2025; Digoxin 0.25mg Tablet – NDC 10135-0748-01, lot# E3811, expiration 2/2025; Consumers/distributors/retailers that have Digoxin Tablets USP, 0.125mg and Digoxin Tablets USP, 0.25mg (lot# E3810 and lot# E3811) which are being recalled should stop using/return to place of purchase. Marlex Pharmaceuticals, Inc. is notifying its distributors and customers by emails and is arranging for return of all recalled products (lot# E3810 and lot# E3811). |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Not supplied
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Fda listing date
- Aug 31, 2023
- Company announcement date
- Aug 30, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.