Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals,
Summary
The FDA issued a Class III for Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx by Sagent Pharmaceuticals. Reason: Failed Impurities/Degradation Specifications.
Details
Source
Drug Recall
External ID
D-0539-2026
Action Date
2026-05-27
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.
Quantity Affected: Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-04
Company
Schaumburg, IL
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 43 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Sagent Pharmaceuticals has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Sagent Pharmaceuticals) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sagent Pharmaceuticals have FDA actions?
Sagent Pharmaceuticals has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0539-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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