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Busulfan Injection
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DRUG RECALLLOW

Busulfan Injection

Sagent Pharmaceuticals is recalling Busulfan Injection (NDC 25021-241-10) due to failed impurities and degradation specifications.

What to do

Contact your healthcare provider or pharmacy to determine if your medication is part of the affected lot and to arrange for a replacement if necessary.

Recalled
Listed
Updated
Recall No.
D-0539-2026
Agency
FDA
Firm
Sagent Pharmaceuticals
Recall ID
98883
Status
ONGOING

Recall at a glance

Quantity recalled
Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.

Why it was recalled

Sagent Pharmaceuticals is recalling Busulfan Injection, 60 mg per 10 mL (6 mg per mL), packaged in 8x10 mL single-dose vials, due to failed impurities and degradation specifications. The affected product is identified by NDC 25021-241-10.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

Busulfan Injection

Lot code
656412, 2026
Strength
60 mg
NDC / UPC
NDC 25021-241-10

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-05-19 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification