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DRUG RECALLLOW
Busulfan Injection
Sagent Pharmaceuticals is recalling Busulfan Injection (NDC 25021-241-10) due to failed impurities and degradation specifications.
What to do
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
Failed Impurities/Degradation Specifications
How to identify it
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.
Where it was sold
Distributed in US.
Official source
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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