FDAFDA · Food and drugs·Recall number D-0539-2026
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.
Published May 27, 2026 · Recall initiated: May 4, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BUSULFAN
- Manufacturer
- Sagent Pharmaceuticals
- Distributor
- Nationwide within the United States
- Lot
- Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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