Why it was recalled
Failed Impurities/Degradation Specifications
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0539-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- May 4, 2026
- FDA report date
- May 27, 2026
- Quantity
- Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sagent Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0539-2026, exactly as published.
Show all FDA fields
- City
- Schaumburg
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 98883
- Address
- 1515 E Woodfield Rd Ste 1100
- Code information
- Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.
- Postal code
- 60173-6067
- Report date
- May 27, 2026
- Product type
- Drugs
- Recall number
- D-0539-2026
- Classification
- Class III
- Recalling firm
- Sagent Pharmaceuticals
- Product quantity
- Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- May 4, 2026
- Initial firm notification
- Letter
- Center classification date
- May 18, 2026