FDA Drug Recalls

Recalls / Class II

Class IID-0337-2026

Product

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.

Affected lot / code info
Lot # C274-000047611, Exp Date: 10-Feb-26; Lot # C274-000049633, Exp Date: 12-May-26.

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm
Fresenius Kabi Compounding, LLC
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
20 Dan Rd, N/A, Canton, Massachusetts 02021-2809

Distribution

Quantity
N/A
Distribution pattern
US Nationwide.

Timeline

Recall initiated
2026-02-05
FDA classified
2026-02-13
Posted by FDA
2026-02-18
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0337-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.