FDA-Drug2026-04-15Class IIPROCESSING DEFECT
Fresenius Kabi sodium chloride injection recalled for lack of sterility assurance
What this means
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.
The agency's original wording
Hazard
Lack of Assurance of Sterility
Intended for
Adults
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, 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 recalls
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