FDA Drugs recall ·
Busulfan Injection, 60 mg per 10 mL (6 mg per mL)… recall
- Recall number
- D-0539-2026
- Date
- (initiated May 4, 2026)
- Company / brand
- Sagent Pharmaceuticals
1515 E Woodfield Rd Ste 1100, Schaumburg, IL, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Failed Impurities/Degradation Specifications
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.
Distribution
Nationwide within the United States
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0539-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.