# 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. — FDA Safety Label Change

> Failed Impurities/Degradation Specifications

**Manufacturer:** Sagent Pharmaceuticals
**Date of action:** 20260527
**Canonical URL:** https://drugsmonitor.com/recall/3d8f3dd2-2bf7-4a99-8d2b-0523ec18a1b8
**Last updated:** 2026-06-11

## Summary

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. (Sagent Pharmaceuticals) — Safety Label Change on 20260527.

Failed Impurities/Degradation Specifications

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*Educational recall record from DrugsMonitor.com. Confirm details with FDA primary sources.*