What was recalled and why?

Sagent Pharmaceuticals recalled 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.. FDA's record states the reason for recall as: Failed Impurities/Degradation Specifications. The recall is logged under FDA recall number D-0539-2026 with a Class III classification.

How serious is this recall?

FDA classifies a recall as Class III when using the recalled product, or being exposed to it, is not likely to cause any adverse health consequences. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What should someone who has this product do?

Because FDA considers adverse health consequences unlikely for a Class III recall, the recommended action is still to stop using the product and follow the recalling firm's instructions, since a recall means the product did not meet FDA requirements. Check the product against FDA's description (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.) and recall number D-0539-2026, then follow Sagent Pharmaceuticals's recall instructions.

Has Sagent Pharmaceuticals had other FDA recalls or enforcement actions?

This is the only FDA action Argus HQ has on file for Sagent Pharmaceuticals so far. Argus ingests new FDA enforcement records daily.

Recall Record: Class III Recall: BUSULFAN by Sagent Pharmaceuticals

At a glance: Sagent Pharmaceuticals recalled 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. on 2026-05-27. FDA classified this action as a Class III recall (recall number D-0539-2026). Reason for recall: Failed Impurities/Degradation Specifications. Recall status: Ongoing. This is a drug-category FDA recall record. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

Key facts

Recalling firm	Sagent Pharmaceuticals
Manufacturer	Sagent Pharmaceuticals
Brand name	BUSULFAN
Product description	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.
Classification	Class III
Recall number	D-0539-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	Failed Impurities/Degradation Specifications

What this classification means

FDA classifies a recall as Class III when using the recalled product, or being exposed to it, is not likely to cause any adverse health consequences. In this case, the recalling firm is Sagent Pharmaceuticals and the affected product is described in FDA's record as: 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.. FDA's stated reason for the recall is: Failed Impurities/Degradation Specifications. The recall is tracked under FDA recall number D-0539-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.

What consumers should do

Because FDA considers adverse health consequences unlikely for a Class III recall, the recommended action is still to stop using the product and follow the recalling firm's instructions, since a recall means the product did not meet FDA requirements. Specifically, check whether the product in your possession matches the description on file with FDA -- 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. -- and the recall number D-0539-2026. If it matches, stop using or distributing it and contact Sagent Pharmaceuticals or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

Sagent Pharmaceuticals’s FDA history

Argus HQ has recorded 1 total FDA action tied to Sagent Pharmaceuticals: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What was recalled and why?: Sagent Pharmaceuticals recalled 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.. FDA's record states the reason for recall as: Failed Impurities/Degradation Specifications. The recall is logged under FDA recall number D-0539-2026 with a Class III classification.
How serious is this recall?: FDA classifies a recall as Class III when using the recalled product, or being exposed to it, is not likely to cause any adverse health consequences. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.
What should someone who has this product do?: Because FDA considers adverse health consequences unlikely for a Class III recall, the recommended action is still to stop using the product and follow the recalling firm's instructions, since a recall means the product did not meet FDA requirements. Check the product against FDA's description (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.) and recall number D-0539-2026, then follow Sagent Pharmaceuticals's recall instructions.
Has Sagent Pharmaceuticals had other FDA recalls or enforcement actions?: This is the only FDA action Argus HQ has on file for Sagent Pharmaceuticals so far. Argus ingests new FDA enforcement records daily.

Know if this happens again — we'll email you.

Free. No spam, just recall alerts for what you tell us to watch.

Full FDA history for Sagent Pharmaceuticals

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Recall Record: Class III Recall: BUSULFAN by Sagent Pharmaceuticals. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-sagent-pharmaceuticals-d-0539-2026

MLA

"Recall Record: Class III Recall: BUSULFAN by Sagent Pharmaceuticals." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-sagent-pharmaceuticals-d-0539-2026.

Chicago

Argus HQ Research. "Recall Record: Class III Recall: BUSULFAN by Sagent Pharmaceuticals." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-sagent-pharmaceuticals-d-0539-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_sagent_pharmaceuticals_d_0539_2026_2026,
  title = {Recall Record: Class III Recall: BUSULFAN by Sagent Pharmaceuticals},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/fda-recall-sagent-pharmaceuticals-d-0539-2026},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Recalls ↗