Recalling firm
Sagent Pharmaceuticals
Product type
Drug
Status
Ongoing
Report date
2026-05-27
Distribution
Nationwide within the United States
Firm state
IL
Product quantity
Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Failed Impurities/Degradation Specifications
Product description
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.
Code / lot info
Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.