Class III · Lower riskActive recall
Busulfan
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed Impurities/Degradation Specifications
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byMade in Canada foreign manufacturer
| Brand name | BUSULFAN |
| Generic name | BUSULFAN |
| Active ingredient(s) | BUSULFAN |
| Distributed by / for | Sagent Pharmaceuticals |
| NDC | 25021-241-10 |
Show the full FDA record
| Full product label | 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. |
| Recalling firm | Sagent Pharmaceuticals |
| Distribution | Nationwide within the United States |
| Quantity | Lot 656412: 6,200 vials. Lot 659646: 3,328 vials. |
| Recall initiated | 2026-05-04 |
| Report date | 2026-05-27 |
| Recall completed | — |
| Recall number | D-0539-2026 |
| Classification | Class III |
| FDA status | Ongoing |
| Origin on file | Schaumburg IL United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.