Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, M
Recalled April 15, 2026 · FDA recall D-0432-2026 · 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 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of Use NDC: 65219-432-20, Unit of Sale NDC Number: 65219-432-85.
Manufacturer(s)
Fresenius Kabi USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →