FDA-Drug2026-04-15Class IIPROCESSING DEFECT
Fresenius Kabi sodium chloride injection recalled for lack of sterility assurance
OTHERNationwide distribution
Stop using Fresenius Kabi saline injection
Fresenius Kabi is recalling specific batches of 0.9% sodium chloride injection (saline) in 1,000 mL freeflex 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 your saline bags for batch numbers: 23SU10001, 24AU10003, 24AU10004, 24AU10005, 24AU10008, 24EU10001, 24EU10002, 24PU10002, 25BU10003, or 25EU10005
- Do not use affected batches; contact your supplier or pharmacy for replacement
- If you have already used this product and have concerns, speak with 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, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical Care RTG, LLC, Manufactured by: Fresenius Kabi, Unit of Use NDC: 65219-282-01, Unit of Sale NDC Number: 65219-282-10.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0433-2026More 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
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief