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 is recalling specific batches of 0.9% Sodium Chloride Injection because the manufacturer cannot guarantee these vials are sterile. This injectable medication is used in hospitals and clinical settings. No injuries have been reported.
- If you administer this medication: check vial labels for batch numbers 6402372, 6402374, 6402437 and expiration dates 08/31/2026 or 10/31/2026
- Do not use recalled batches; remove them from stock
- Contact your pharmacy, hospital, or healthcare supplier for replacement stock
- Ask your healthcare provider if you received this injection and need follow-up
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% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-466-05, Unit of Sale NDC Number: 65219-466-60.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0425-2026More 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
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