# FDA recall D-0443-2024

> **Novitium Pharma LLC** · Class III · drug recall initiated 2024-03-25.

## Product

Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-200-10

## Reason for recall

Failed Impurities/Degradation Specifications

## Distribution

U.S. Nationwide

## Key facts

- **Recall number:** D-0443-2024
- **Recalling firm:** Novitium Pharma LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-03-25
- **Report date:** 2024-04-24
- **Termination date:** 2024-07-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Windsor, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0443-2024

## Citation

> AI Analytics. FDA recall D-0443-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0443-2024. Source: US FDA. Licensed CC0.

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