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.

FDA recall notice · announced May 27, 2026 · Sagent Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Notes

Distribution: Nationwide within the United States
Lot/code information: Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.
Quantity: Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.
Status: Ongoing
Products in this recall event:
- 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. (D-0539-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.