FDA recall D-0820-2026

Baxter Healthcare Corporation · Class II · drug

Product

Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3583-01.

Reason for recall

CGMP Deviations

Distribution

US Nationwide; Puerto Rico; and Chile.

Key facts

Status
Ongoing
Initiation date
2026-08-06
Report date
2026-09-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0820-2026