FDA recall D-0539-2026

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.

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

Nationwide within the United States

Key facts

Status

Ongoing

Initiation date

2026-05-04

Report date

2026-05-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Schaumburg, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0539-2026