FDA recall, , Low risk
Sagent Pharmaceuticals Busulfan Injection
Busulfan Injection failed impurities and degradation specifications.
Summary by Recall Canary from the FDA notice
What happened
Sagent Pharmaceuticals, of Schaumburg, Illinois, recalled Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, because it failed impurities and degradation specifications. The company began the recall on May 4, 2026, and the FDA added it to the Enforcement Report on May 18, 2026. The product was distributed nationwide within the United States.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
- NDC
- 25021-241-10
- Lot code
- 656412
- 659646
Recall details
- Company began the recall
- Sold in
Nationwide within the United States
- Company
- Sagent PharmaceuticalsSchaumburg, Illinois
- Hazard
- Drug impurity
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 98883
- Recall number
- D-0539-2026
- Quantity recalled
- Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
