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 to meet purity standards and showed signs of degradation. This is a prescription chemotherapy drug used before bone marrow transplants. The recall affects all U.S. states and was classified as a Class III recall, meaning use of the product is unlikely to cause serious harm but does not meet quality specifications.
- 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/3067f160-a5fe-4a0d-a149-90cf3e64d1f9