Busulfan Injection recall
FDA recall D-0539-2026 · initiated May 4, 2026
Sagent Pharmaceuticals recalled Busulfan Injection in May 2026 — an FDA Class III recall (D-0539-2026) because Failed Impurities/Degradation Specifications.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Impurities/Degradation Specifications
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.
Details
- 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.
- Recalling company
- Sagent
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- May 4, 2026
- FDA report date
- May 27, 2026
Frequently asked
- Was Busulfan Injection recalled?
- Sagent Pharmaceuticals recalled Busulfan Injection in May 2026 — an FDA Class III recall (D-0539-2026) because Failed Impurities/Degradation Specifications. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Busulfan Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0539-2026 was: Failed Impurities/Degradation Specifications
- Is a recalled Busulfan Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Busulfan Injection are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0539-2026.