FDA-Drug2026-04-15Class IIPROCESSING DEFECT
Fresenius Kabi sodium chloride injection recalled for sterility assurance
What this means
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
The agency's original wording
Hazard
Lack of Assurance of Sterility
Intended for
All ages (under 100 years)
Illnesses reported
None reported
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 recalls
- FDA-Drug2026-07-29Fresenius Kabi glycopyrrolate injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi Xylocaine lidocaine injection recalled for hair contamination
- 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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