FDA Drug recall D-0539-2026
Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 6019…
- FDA Drug
- Class III
- ongoing
- Published 2026-05-27
On 2026-05-27 the FDA classified a Class III recall of Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 6019… by Sagent Pharmaceuticals, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0539-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-05-04 |
| Published | 2026-05-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sagent Pharmaceuticals |
| Distribution | US |
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
Failed Impurities/Degradation Specifications
Identifiers
| ndc | 25021-241-10 |
|---|---|
| code_info | Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0539-2026%22
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