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Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fres

Recalled April 15, 2026 · FDA recall D-0425-2026 · 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% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-466-05, Unit of Sale NDC Number: 65219-466-60.
Manufacturer(s)
Fresenius Kabi USA, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fres | RecallWatchUSA