Busulfan Injection — Class III drug recall D-0539-2026
Ongoing recall by Sagent Pharmaceuticals, reported 2026-05-27, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-0539-2026 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sagent Pharmaceuticals, Schaumburg, IL, United States |
| Recall initiated | 2026-05-04 |
| Classified | 2026-05-18 |
| Reported by FDA | 2026-05-27 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 25021-0241, 25021-0241-10 |
| Lot numbers | 656412, 659646 |
| Expiration dates | 2026-08-31, 2027-03-31 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0539-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.