FDA Drug recall D-1169-2023
Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc
- FDA Drug
- Class I
- terminated
- Published 2023-09-13
On 2023-09-13 the FDA classified a Class I recall of Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc by Marlex Pharmaceuticals, citing labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tab….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1169-2023 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2023-08-25 |
| Published | 2023-09-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Marlex Pharmaceuticals |
| Distribution | US |
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
Reason
Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.
Identifiers
| code_info | Lot # E3810, expiration date 02/2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1169-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.