FDA recall D-0427-2026

Product

0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-470-05, Unit of Sale NDC Number: 65219-470-30.

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-0427-2026