# FDA recall D-0103-2025

> **AvKARE** · Class II · drug recall initiated 2024-10-18.

## Product

Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28

## Reason for recall

Labeling: Label Mix-Up

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0103-2025
- **Recalling firm:** AvKARE
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-10-18
- **Report date:** 2024-12-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pulaski, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0103-2025

## Citation

> AI Analytics. FDA recall D-0103-2025. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0103-2025. Source: US FDA. Licensed CC0.

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