Busulfan Injection recall: Impurity Out of Spec
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…
Why was Busulfan Injection recalled?
Failed Impurities/Degradation Specifications
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.
- 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…
- Recalling firm
- Sagent Pharmaceuticals
- Quantity
- Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.
- Distribution
- Nationwide within the United States
- Recall date
- May 27, 2026
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (drug)