FDA-Drug2026-04-15Class IIPROCESSING DEFECT
Fresenius Kabi sodium chloride injection recalled for lack of sterility assurance
OTHERNationwide distribution
Stop using Fresenius Kabi saline injection
Fresenius Kabi is recalling specific batches of 0.9% Sodium Chloride Injection (saline) in 100 mL bags due to lack of assurance of sterility. The affected batches were distributed nationwide, including Alaska and Puerto Rico. No injuries have been reported.
- Check the batch number and expiration date on your saline bags against the recalled batches (6402299, 6402300, 6402301, 6402302, 6402303, 6402305, 6402398, 6402467, 6402577, 6402578).
- Do not use affected bags. Contact your healthcare facility or pharmacy for instructions on safe disposal and replacement.
- If you or someone in your care received this product, inform your healthcare provider.
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, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 600047, Unit of Use NDC: 65219-468-05, Unit of Sale NDC Number: 65219-468-50.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0426-2026More 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 sterility assurance
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for sterility assurance issue
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