Reported May 27, 2026 · Ongoing
Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals,…
Sagent Pharmaceuticals
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sagent Pharmaceuticals · 1515 E Woodfield Rd Ste 1100 · Schaumburg, IL · 60173-6067
Is this the product you have?
- 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.
- Lot codes and dates
Lot #: 656412Exp. Date 08/31/2026659646Exp. Date 03/31/2027
- Amount recalled
- Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Sagent Pharmaceuticals recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.