FDA recall D-0596-2025

Baxter Healthcare Corporation · Class II · drug

Product

Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in Ireland, NDC 36000-306-60.

Reason for recall

Discoloration

Distribution

U.S.A. Nationwide

Key facts

Status: Ongoing
Initiation date: 2025-08-20
Report date: 2025-09-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0596-2025