FDA Drug · 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.

Class III · Ongoing

Failed Impurities/Degradation Specifications

Affected lots / codes — check yours against thisLot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.

Recalling firm: Sagent Pharmaceuticals, Schaumburg, IL
Classification: Class III (unlikely to cause harm)
Status: Ongoing
Quantity: Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.
Distribution: Nationwide within the United States
Recall initiated: May 4, 2026
Classified: May 18, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0539-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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