# FDA recall D-0539-2026

> **Sagent Pharmaceuticals** · Class III · drug recall initiated 2026-05-04.

## Product

Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10.

## Reason for recall

Failed Impurities/Degradation Specifications

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0539-2026
- **Recalling firm:** Sagent Pharmaceuticals
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-05-04
- **Report date:** 2026-05-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Schaumburg, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0539-2026

## Citation

> MORVS. FDA recall D-0539-2026. Retrieved 2026-10-17 from https://api.morvs.ai/recall/D-0539-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*