FDA recall D-0805-2026

Product

Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3552-48.

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-0805-2026