FDA-Drug2026-04-15Class IIPROCESSING DEFECT
Fresenius Kabi sodium chloride injection recalled for sterility assurance
OTHERNationwide distribution
Stop using Fresenius Kabi sodium chloride injection
Fresenius Kabi is recalling specific batches of 0.9% Sodium Chloride Injection due to a lack of assurance that the product is sterile. This injectable solution is used in medical settings and could pose a risk if contaminated. No injuries have been reported to date.
- Check if you have Batch# 24LU10013, 24LU10014, 24NU10001, or 24NU10002 (expiring 09/30/2027 or 10/31/2027)
- Do not use affected batches; quarantine them immediately
- Contact your pharmacy, hospital, or healthcare provider if you have questions about whether your supply is affected
- Report any use of recalled product to the FDA MedWatch program
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
0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0428-2026More 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 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 issue
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