Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fr
Recalled April 15, 2026 · FDA recall D-0426-2026 · 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, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 600047, Unit of Use NDC: 65219-468-05, Unit of Sale NDC Number: 65219-468-50.
Manufacturer(s)
Fresenius Kabi USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →