Sagent Pharmaceuticals recalls Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals,
Recalled May 27, 2026 · FDA recall D-0539-2026 · Sagent Pharmaceuticals
Hazard
Failed Impurities/Degradation Specifications · FDA Class III
Units
Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.
Sold at
Nationwide within the United States
Description
Failed Impurities/Degradation Specifications
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.
Manufacturer(s)
Sagent Pharmaceuticals
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →