Sagent Pharmaceuticals recalls Busulfan Injection
- Recalling company
- 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 – not likely to cause adverse health consequences
- Recall date
- May 4, 2026
- Reported
- May 27, 2026
- Distribution
- Nationwide within the United States
- Status
- Ongoing
- Quantity
- Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.
- Lot / codes
- Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.
- Company location
- Schaumburg, IL
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0539-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0539-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.