Sagent Pharmaceuticals: Busulfan Injection, 60 Mg Per
Recall Summary Sagent Pharmaceuticals is recalling Busulfan Injection (60 mg per 10 mL vials) distributed nationwide because the medication failed quality testing for impurities and degradation. This is a Class III recall affecting the product with NDC 25021-241-10, which was manufactured in Canada for Sagent Pharmaceuticals. The recall applies to patients who received this injectable drug, which is used in certain medical treatments requiring a prescription.
- Recalling firm
- 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
- Classification
- Class III
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-05-04
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within the United States
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/284e97d1-796c-44c2-b79a-53013a0a53a6