Sagent Pharmaceuticals recalls Busulfan injection vials due to potential impurities. Affected lots expire 08/31/2026 and 03/31/2027. Contact for return instructions.
Failed Impurities/Degradation Specifications
Sagent Pharmaceuticals is recalling Busulfan injection vials that may contain impurities. This could affect patients using the medication as part of their cancer treatment. The recall is for specific lots with expiration dates in 2026 and 2027.
The vials may contain impurities that could affect the medication's safety and effectiveness. This could lead to adverse reactions in patients receiving the drug for cancer treatment.
Patients prescribed Busulfan injection for cancer treatment who own the recalled vials. Those using the medication as directed are most at risk.
Check for vials labeled 'Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only'. Look for lot numbers 656412 (expiring 08/31/2026) or 659646 (expiring 03/31/2027).
Identify the lot number and expiration date on the vial label to confirm if it's affected.
The recall is for vials that may contain impurities, which could affect medication safety. The official notice does not specify the exact risk level.
Check for vials with lot numbers 656412 (expiring 08/31/2026) or 659646 (expiring 03/31/2027).
The recall notice does not specify a remedy, so contact Sagent Pharmaceuticals for instructions.
We’ve drafted a message you can send Sagent Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0539-2026 — Sagent Pharmaceuticals Sagent Pharmaceuticals Hello, I own a Sagent Pharmaceuticals that is covered by recall D-0539-2026 from Sagent Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
