FDA-Drug2026-04-15Class IIPROCESSING DEFECT
Fresenius Kabi sodium chloride injection recalled for sterility concerns
OTHERNationwide distribution
Stop using Fresenius Kabi saline injection
Fresenius Kabi is recalling specific batches of 0.9% Sodium Chloride Injection (saline solution) used in medical settings because the manufacturer cannot guarantee the product is sterile. The affected batches were distributed nationwide. No injuries have been reported so far.
- If you use or administer this product, check the batch number and expiration date against the recall (Batch# 23DU10004, Exp 04/30/2026 or Batch# 23HU10006, Exp 06/30/2026)
- Do not use recalled batches; return them to your pharmacy or healthcare facility
- Contact your doctor or pharmacist if you have questions about your care
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 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of Use NDC: 65219-432-20, Unit of Sale NDC Number: 65219-432-85.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0432-2026More 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 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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