# FDA recall D-1170-2023

> **Marlex Pharmaceuticals, Inc.** · Class II · drug recall initiated 2023-08-25.

## 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

## 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.

## Distribution

Nationwide in the US.

## Key facts

- **Recall number:** D-1170-2023
- **Recalling firm:** Marlex Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-08-25
- **Report date:** 2023-09-13
- **Termination date:** 2024-04-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** New Castle, DE, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1170-2023

## Citation

> AI Analytics. FDA recall D-1170-2023. Retrieved 2026-08-13 from https://api.ai-analytics.org/recall/D-1170-2023. Source: US FDA. Licensed CC0.

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