Class IIIOngoing

Busulfan Injection recall

FDA recall D-0539-2026 · initiated May 4, 2026

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

Why it was recalled

Failed Impurities/Degradation Specifications

Details

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.
Recalling company: Sagent Pharms Inc
Classification: Class III
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide within the United States
Initiated: May 4, 2026
FDA report date: May 27, 2026

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0539-2026 ↗

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