Sagent Pharmaceuticals recalls Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals,…

Recall date

May 4, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0539-2026

FDA classification

Class III

Brand / firm

Sagent Pharmaceuticals

Sold / distributed

Nationwide within the United States

Why it was recalled

Failed Impurities/Degradation Specifications

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.