FDA-Drug2026-04-15Class IIPROCESSING DEFECT
Fresenius Kabi sodium chloride injection recalled for sterility concerns
What this means
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.
The agency's original wording
Hazard
Lack of Assurance of Sterility
Intended for
All ages (0 months and older)
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, 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 recalls
- FDA-Drug2026-07-29Fresenius Kabi glycopyrrolate injection recalled for hair contamination
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- FDA-Drug2026-07-29Fresenius Kabi lidocaine injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi Xylocaine lidocaine injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi Naropin injection recalled for hair contamination
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