Official recall notice

FDA DrugClass IIINotable

FDA Recall: Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sage

Recall date
2026-05-27
Category
Drug
FDA class
Class III

Why it was recalled

Hazard

Failed Impurities/Degradation Specifications

Recommended action

What to do

Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.

Product description

Failed Impurities/Degradation Specifications

Verify with the official notice →
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