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Limited official informationFDA Drug Enforcement ReportsRecall date: May 27, 2026

Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60...

Full official 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.

Verification delayed

The last verified facts remain visible. Last successful verification: Aug 5, 2026, 7:44 AM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

Missing: action. The page is public for lookup but excluded from search indexing and advertising.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

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.

Identifiers to compare

  • NDC 25021-241-10
Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
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,...Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.D-0539-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

Failed Impurities/Degradation Specifications

Agency classification: Class III

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

Nationwide within the United States

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.