Drug recall D-0539-2026
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.
Reason for recall
Failed Impurities/Degradation Specifications
Lots and codes
Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.
Recall details
- Recalling firm
- Sagent Pharmaceuticals, Schaumburg, IL
- Quantity
- Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 4, 2026
Related products
- Busulfan – drug information
- NDC 25021-241 Busulfan · Busulfan 6 mg/mL · Sagent Pharmaceuticals