Vancomycin HCl recalled over sterility concerns
- Recall date
- February 5, 2026
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Fresenius Kabi Compounding, LLC recalls vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan…
- Recall number
- D-0337-2026
- FDA classification
- Class II
- Brand / firm
- Fresenius Kabi Compounding, LLC
- Sold / distributed
- US Nationwide.
Why it was recalled
Lack of Assurance of Sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-019-59.
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