Class III

Drug Recall: 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 · May 4, 2026

Reason for Recall

Failed Impurities/Degradation Specifications

Distribution

Nationwide within the United States

States Affected

NATIONWIDE

Quantity Affected

Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0539-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Sagent Pharmaceuticals Drug Recall: 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. | SafeCheck