FDA recall D-0437-2026

Product

5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-458-05, Unit of Sale NDC Number: 65219-458-30.

Reason for recall

Lack of Assurance of Sterility

Distribution

US Nationwide , Alaska, and Puerto Rico.

Key facts

Status

Ongoing

Initiation date

2026-03-11

Report date

2026-04-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Zurich, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0437-2026