FDA-Drug2026-04-15Class IIPROCESSING DEFECT
Fresenius Kabi sodium chloride injection recalled for sterility assurance
OTHERNationwide distribution
Stop using Fresenius Kabi saline injection
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.
Hazard
Lack of Assurance of Sterility
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 USA, LLC recalls
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for sterility assurance
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for sterility concerns
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for lack of sterility assurance
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for sterility assurance
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for sterility assurance issue
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