Busulfan Recall: Sagent 60 mg/10 mL 8x10 mL Vials
Announced 2026-05-27 · FDA
The FDA is recalling Busulfan Injection, 60 mg per 10 mL (6 mg per mL) in 8x10 mL single-dose vials manufactured for Sagent Pharmaceuticals in Canada, distributed nationwide. The recall is due to failed impurities/degradation specifications for Lot 656412 (6,200 vials; Exp 08/31/2026) and Lot 659646 (3,328 vials; Exp 03/31/2027). No corrective action is specified.
| Brand | Sagent Pharmaceuticals |
|---|---|
| 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 |
| Severity | low |
| Units affected | 656412 |
| Distribution | Nationwide within the United States |
| Agency | FDA |
| Recall / campaign no. | Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027. |
WHAT YOU SHOULD DO
- Do not use any remaining vials from these lots.
- If you have affected product, contact your prescriber or pharmacist for guidance and possible replacement.
- Check the lot number on your vials (656412 or 659646) and note the expiration dates (08/31/2026 or 03/31/2027).
- Follow pharmacist or FDA guidance for returning or disposing of the product.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.