Busulfan Injection
Sagent Pharmaceuticals is recalling Busulfan Injection (NDC 25021-241-10) due to failed impurities and degradation specifications.
Contact your healthcare provider or pharmacy to determine if your medication is part of the affected lot and to arrange for a replacement if necessary.
Why it was recalled
Sagent Pharmaceuticals is recalling Busulfan Injection, 60 mg per 10 mL (6 mg per mL), packaged in 8x10 mL single-dose vials, due to failed impurities and degradation specifications. The affected product is identified by NDC 25021-241-10.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
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 #
- D-0539-2026
Where it was sold
Distributed nationwide.
Official source
Editorial summary by Recall Canary · last updated 2026-05-19 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification