FDA-Drug2026-02-18Class IIPROCESSING DEFECT
Fresenius Kabi vancomycin HCl injection recalled for lack of sterility assurance
What this means
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
The agency's original wording
Hazard
Lack of Assurance of Sterility
Intended for
Adults
Illnesses reported
None reported
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-0337-2026Want us to check the next one for you?
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