Official recall notice
FDA DrugClass IIINotable
Busulfan Injection per Recall (May 2026) – Sagent Pharmaceuticals
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.
- Recall date
- 2026-05-27
- Category
- Drug
- FDA class
- Class III
Why it was recalled
Hazard
Failed Impurities/Degradation Specifications
Product description
Failed Impurities/Degradation Specifications