FDA-Drug2026-02-18Class IIPROCESSING DEFECT
Fresenius Kabi vancomycin HCl IV solution recalled for sterility concerns
What this means
Fresenius Kabi Compounding issued a recall of vancomycin HCl 1.5 grams in 500 mL sodium chloride solution due to lack of assured sterility. The affected lot (C274-000049628, expiring May 3, 2026) was distributed nationwide to healthcare facilities. No injuries have been reported.
- If your facility received this medication, stop using it immediately
- Check your inventory for lot # C274-000049628
- Contact your pharmacy supplier or Fresenius Kabi for return instructions
- Verify patient records if this lot was administered and consult your healthcare provider if needed
The agency's original wording
Hazard
Lack of Assurance of Sterility
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide.
Affected count
1578 bags
Manufactured in
20 Dan Rd, N/A, Canton, MA, United States
Products
vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0336-2026Want us to check the next one for you?
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