Digoxin Tablets — Class I drug recall D-1169-2023
Terminated recall by Marlex Pharmaceuticals, Inc., reported 2023-09-13, distributed nationwide. Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg a
| Recall number | D-1169-2023 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Marlex Pharmaceuticals, Inc., New Castle, DE, United States |
| Recall initiated | 2023-08-25 |
| Classified | 2023-09-18 |
| Reported by FDA | 2023-09-13 |
| Terminated | 2024-04-17 |
| Distributed | Nationwide (US) |
| Quantity | 94 |
| Reason classes | labeling |
| NDC | 10135-0747-01 |
| Lot numbers | E3810 |
| Expiration dates | 2025-02 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1169-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.