FDA recall D-0812-2026

Product

Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Dose Infusion Bag in 100 mL GALAXY Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, NDC 0338-9648-12.

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-0812-2026