HIGH

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

Quick Facts at a Glance

Recall Date
May 4, 2026
Hazard Level
HIGH
Brands
BUSULFAN, Sagent Pharmaceuticals
Geographic Scope
1 states

Hazard Information

Failed Impurities/Degradation Specifications

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Sagent Pharmaceuticals or your healthcare provider for guidance. Notification method: Letter

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Full 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.. Generic: BUSULFAN; Brand: BUSULFAN. Reason: Failed Impurities/Degradation Specifications. Classification: Class III. Quantity: Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.. Distribution: Nationwide within the United States

Safety Guide

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Product Classification

Product Details

Model Numbers
Lot #: 656412
Exp. Date 08/31/2026
659646
Exp. Date 03/31/2027.
UPC Codes
25021-241
25021-241-10
Affected States
ALL
Report Date
May 27, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE