Fresenius Kabi Sodium Chloride Injection Recall
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, LL
Updated March 11, 2026
Fresenius Kabi is recalling a 0.9% Sodium Chloride Injection due to lack of assurance of sterility. This injectable medication may not be sterile, which could cause serious infection if used.
Is the Fresenius Kabi USA, LLC recalled? Yes. This product was recalled by FDA on March 11, 2026. Details below.
What is recalled
0.9% Sodium Chloride Injection, USP (900 mg per 100 mL) in 100 mL Freeflex bags. Product manufactured by Fresenius Kabi USA, LLC, Lake Zurich, IL. Unit of Use NDC: 65219-468-05. Unit of Sale NDC: 65219-468-50. Prescription only.
Am I affected
You're affected if you have this medication in your possession with NDC number 65219-468-05 or 65219-468-50 on the package label, or if you recently received this IV saline injection from a healthcare provider.
What to do right now
Do not use this product. If you have received this injection as a patient, contact your healthcare provider immediately. Healthcare facilities should contact Fresenius Kabi USA or their supplier for recall instructions and replacement product.
The hazard
Lack of Assurance of Sterility
Brands affected
- Source
- FDA
- Category
- Drugs & Medications
- Recall ID
- fda-D-0426-2026
- Classification
- Class II
- Recalled
- March 11, 2026
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