Fresenius Kabi Compounding recalled its vancomycin HCl injection on February 5, 2026, due to a lack of assurance of sterility. This Class II recall affects all lots distributed nationwide. Healthcare providers and consumers must stop using the product immediately.
Lack of Assurance of Sterility
Consumers and healthcare providers should stop using this product immediately. Contact Fresenius Kabi Compounding, LLC or your healthcare provider for guidance. Notification method: Letter
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The recalled product is vancomycin HCl, 2 grams, added to 500 mL of 0.9% Sodium Chloride Injection. Model numbers include Lot # C274-000047611 (Exp Date: 10-Feb-26) and Lot # C274-000049633 (Exp Date: 12-May-26).
The recall stems from a lack of assurance of sterility, which can lead to serious infections if contaminated. Sterility assurance is critical for injectable medications to prevent health risks.
No specific incidents or injuries have been reported related to this recall. However, the potential for serious health risks exists due to contamination.
Stop using the product immediately. Contact Fresenius Kabi Compounding or your healthcare provider for further guidance. Expect notification letters regarding the recall.
For more information, call Fresenius Kabi Compounding at 1-800-XXX-XXXX or visit [FDA Recall](https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0337-2026).
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