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FDAMay 4, 2026drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Failed Impurities/Degradation Specifications

What to do

FDA enforcement status: Ongoing

Brands named

sagent pharmaceuticalssagent

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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