Recall: D-0539-2026

Class III - Minor Violations

Class IIIClassification

2026-05-04Initiated

OngoingStatus

Sagent PharmaceuticalsFirm

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

Failed Impurities/Degradation Specifications

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.