Fresenius Kabi 5% Dextrose Injection Recall for Sterility Concerns (2026) Affecting US Nationwide, R
Lack of Assurance of Sterility
990 recalls tagged with “adult product”.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Fresenius Kabi USA recalls 0.9% Sodium Chloride Injection units distributed nationwide, including Alaska and Puerto Rico. The recall cites lack of assurance of sterility. Healthcare providers should stop use and contact Fresenius Kabi for guidance.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.