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 USA is recalling multiple batches of 0.9% Sodium Chloride Injection (saline solution) used for medical purposes because the manufacturer cannot guarantee the product is sterile. The affected batches were distributed nationwide, Alaska, and Puerto Rico. No injuries have been reported.
- Check if you have any Fresenius Kabi 0.9% Sodium Chloride Injection 250 mL freeflex bags with batch numbers and expiration dates matching the recall list
- Do not use recalled batches; return them to your pharmacy or healthcare provider immediately
- Contact your doctor or pharmacist if you have already used product from a recalled batch
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, (2,250 mg per 250 mL) (9 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: 65219-470-05, Unit of Sale NDC Number: 65219-470-30.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0427-2026More 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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