Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Frese
Recalled April 15, 2026 · FDA recall D-0428-2026 · Fresenius Kabi USA
Hazard
Lack of Assurance of Sterility · FDA Class II
Sold at
US Nationwide , Alaska, and Puerto Rico.
Description
Lack of Assurance of Sterility
Product
0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20.
Manufacturer(s)
Fresenius Kabi USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →