FDA-Drug2026-05-27Class IIICHEMICAL
Sagent Pharmaceuticals Busulfan Injection recalled for failed impurity and degradation specifications
What this means
Sagent Pharmaceuticals is recalling two lots of Busulfan Injection due to failed impurities and degradation specifications. The affected lots are 656412 (expiring 08/31/2026) and 659646 (expiring 03/31/2027). This is a prescription medication used in cancer treatment.
- Check your pharmacy records or hospital records to see if you received this medication from the affected lots.
- Contact your prescribing physician or pharmacist if you have one of the affected lots in your possession.
- Do not use the medication if you have lot 656412 or 659646.
The agency's original wording
Hazard
Failed Impurities/Degradation Specifications
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the United States
Affected count
Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.
Manufactured in
1515 E Woodfield Rd Ste 1100, Schaumburg, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0539-2026Want us to check the next one for you?
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