FDA•CRITICAL
Tyenne (tocilizumab-aazg) Injection 400 mg/20 mL
Fresenius Kabi recalls Tyenne ( (tocilizumab-aazg) 400 mg/20 mL vials over glass particles.
Fresenius Kabi USA, LLC
Fresenius Kabi USA, LLC: 8 recalls listed since April 2026 across FDA; 4 rated CRITICAL.
By year
- 20268
By agency
- FDA8
By category
- Drug5
- Medical Device3
All recalls (8)
FDA•CRITICALMorphine Sulfate Injection 2 mg/mL Prefilled SyringesFresenius Kabi recalls Morphine Sulfate 2 mg/mL syringes over a label mixup that may contain Dilaudid.
2 products
FDA•MODERATEFresenius Kabi: Multiple Rx Only InjectionsFresenius Kabi recalls injectables due to hair particulate matter.
5 products
FDA•LOWEpinephrine Injection 1mg/mLFresenius Kabi is recalling Epinephrine Injection 1mg/mL vials due to out-of-specification stability test results.
- Device RecallFDA•CRITICALIvenix Infusion System LVP Software
Fresenius Kabi is recalling Ivenix Infusion System LVP software due to a potential battery-health reporting error that may cause pump shutdown.
FDA•MODERATEIvenix Infusion System Large Volume PumpFresenius Kabi is recalling the Ivenix Infusion System LVP due to a risk of the cassette loading lever breaking during use.
FDA•CRITICALIvenix Large Volume PumpFresenius Kabi is recalling Ivenix Large Volume Pumps due to potential touchscreen malfunctions caused by internal damage from drops or jarring.
FDA•MODERATEFresenius Kabi: Multiple Sale NDC Number InjectionsFresenius Kabi recalls 14 lots of Sodium Chloride and Dextrose Injections due to sterility concerns.
14 products