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 USA is recalling specific batches of 0.9% Sodium Chloride Injection (saline) because the manufacturer cannot confirm the product is sterile. Sterility is critical for injectable medications. The affected batches have expiration dates of October 31, 2026, or November 30, 2026.
- Check your saline injection bottles for batch numbers 6402428, 6402481, or 6402482 and the expiration dates listed above.
- Do not use affected bottles. Contact your healthcare provider or pharmacy for replacement.
- If you have already used saline from these batches, 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, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-02.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0429-2026More 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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