Busulfan Recall: Sagent 60 mg/10 mL 8x10 mL Vials
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 |
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.
How to identify the recalled item
| Lot / date codes | Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027. |
|---|---|
| Lot / date codes | Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
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.