FDAHealthMay 4, 2026
Sagent Pharmaceuticals — 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.
⚠️ Failed Impurities/Degradation Specifications
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 4, 2026
Nationwide within the United States
What's affected?
- 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.
- Brand
- BUSULFAN
- Lot code
- 656412
Additional details
Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: Lot 656412: 6,200 vials. Lot 659646: 3,328 vials..
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