FDA-Drug2026-04-15Class IIPROCESSING DEFECT
Fresenius Kabi sodium chloride injection recalled for sterility assurance
What this means
Fresenius Kabi is recalling one batch of 0.45% sodium chloride injection (saline solution) used in hospitals and medical facilities because the manufacturer cannot guarantee the product is sterile. The affected batch is #6402413 with an expiration date of 02/29/2028. No infections or injuries have been reported so far.
- If you work in a hospital or medical facility, stop using batch #6402413 immediately.
- Contact Fresenius Kabi or your medical supplier about returning the affected product.
- Report any use of this batch to your healthcare provider or pharmacist.
The agency's original wording
Hazard
Lack of Assurance of Sterility
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide , Alaska, and Puerto Rico.
Manufactured in
3 Corporate Dr, Lake Zurich, IL, United States
Products
0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0424-2026More Fresenius Kabi recalls
- FDA-Drug2026-07-29Fresenius Kabi glycopyrrolate injection recalled for hair contamination
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- FDA-Drug2026-07-29Fresenius Kabi lidocaine injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi Xylocaine lidocaine injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi Naropin injection recalled for hair contamination
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