FDA recall D-0337-2026

Fresenius Kabi Compounding, LLC · Class II · drug

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.

Reason for recall

Lack of Assurance of Sterility

Distribution

US Nationwide.

Key facts

Status: Ongoing
Initiation date: 2026-02-05
Report date: 2026-02-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Canton, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0337-2026