Busulfan Injection recall (Sagent Pharmaceuticals)
DrugClass IIIOngoing
Summary: Sagent Pharmaceuticals is recalling 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.
What is being recalled
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.
Why
Failed Impurities/Degradation Specifications
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
Nationwide within the United States
How to tell if yours is affected
Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0539-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | May 4, 2026 |
| Reported | May 27, 2026 |
| Company | Sagent Pharmaceuticals |
| Company location | Schaumburg, IL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | Lot 656412: 6,200 vials. Lot 659646: 3,328 vials. |
More recalls from Sagent Pharmaceuticals · all drug recalls · recalls from May 2026