FDA-Drug2026-02-18Class IIPROCESSING DEFECT
Fresenius Kabi vancomycin HCl injection recalled for lack of sterility assurance
OTHERNationwide distribution
Stop using recalled Fresenius Kabi vancomycin injection
Fresenius Kabi Compounding has recalled vancomycin HCl 2-gram doses mixed in sodium chloride solution due to concerns that sterility cannot be assured. The affected lots were distributed nationwide. This is a serious issue because non-sterile injectables can cause life-threatening infections.
- Check your medicine supply for vancomycin with lot numbers C274-000047611 (expires 10-Feb-26) or C274-000049633 (expires 12-May-26)
- Do not use vancomycin from these lots
- Contact your pharmacy, hospital, or healthcare provider immediately if you have received doses from these lots
- Speak with your doctor about alternative treatment if this antibiotic was prescribed to you
Hazard
Lack of Assurance of Sterility
Sold states
US Nationwide.
Affected count
N/A
Manufactured in
20 Dan Rd, N/A, Canton, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0337-2026Don't want to check this manually?
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