Busulfan Injection Recalled for Failed Impurities and Degradation Specifications
Sagent Pharmaceuticals is recalling two lots of Busulfan Injection due to failed impurities and degradation specifications. The affected lots were distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source text does not describe a hazard that poses imminent risk of adverse health consequences. This is an FDA Class III recall, which by definition is unlikely to cause adverse health consequences. No illnesses, injuries, or specific clinical harm are reported in the source.
Plain-English summary
Sagent Pharmaceuticals is recalling Busulfan Injection, 60 mg per 10 mL (6 mg per mL), supplied as 8×10 mL single-dose vials. The recall affects Lot 656412 (expiration 08/31/2026) and Lot 659646 (expiration 03/31/2027). The product was manufactured for Sagent Pharmaceuticals in Schaumburg, Illinois, and made in Canada.
The recall was initiated because these lots failed impurities and degradation specifications. The affected product was distributed nationwide within the United States.
Patients currently using this medication should contact their healthcare provider or pharmacist for guidance. Healthcare providers should verify whether they have received product from the affected lots and take appropriate action to ensure patient safety.
The recalled product
- Product
- BUSULFAN (BUSULFAN)
- Brand
- BUSULFAN
- Manufacturer
- Sagent Pharmaceuticals
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: 656412
- Exp. Date 08/31/2026
- 659646
- Exp. Date 03/31/2027.
Distribution
Distributed nationwide across the United States.
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