Busulfan recalls
Busulfan products have been recalled 1 time, most recently on 27 May 2026. The recalling company is usually Sagent Pharmaceuticals. The most common reason is potency & assay.
Total recalls1since 2026
Last 12 months1reported
Class I00% of total
Ongoing1latest 27 May 2026
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 0 0%Class III 1 100%
Why busulfan is recalled
Companies
Product types
By year
Ongoing busulfan recalls
1 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Busulfan Injection, 60 mg per (6 mg per mL), mL Single-Dose Vials recalledBusulfan | Sagent Pharmaceuticals | Potency & Assay | Nationwide |
All busulfan recalls, newest first
1 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Busulfan Injection, 60 mg per (6 mg per mL), mL Single-Dose Vials recalledBusulfan | Sagent Pharmaceuticals | Potency & Assay | Nationwide |
About this list
Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.