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Drug FDA Class III Ongoing Failed specifications

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.

Sagent Pharmaceuticals Published May 27, 2026

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Sagent Pharmaceuticals or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Failed Impurities/Degradation Specifications

Hazards

Failed Impurities/Degradation Specifications · primary

Affected products (1)

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.

BUSULFAN · Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.

NDC: 25021-241, 25021-241-10
Code info: Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.

Affected areas

Nationwide

Timeline

  1. Initiated
    May 4, 2026
  2. Published
    May 27, 2026
Recall number
D-0539-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.