Fresenius Kabi USA, LLC recalls

27 recalls.

• Tyenne recall (Fresenius Kabi USA, LLC)
  DrugClass IReported September 2, 2026 · Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
• Morphine Sulfate Injection recall (Fresenius Kabi USA, LLC)
  DrugClass IReported August 26, 2026 · Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
• Xylocaine recall (Fresenius Kabi USA, LLC)
  DrugClass IIReported July 29, 2026 · Presence of Particulate Matter: Hair was found in products
• Xylocaine recall (Fresenius Kabi USA, LLC)
  DrugClass IIReported July 29, 2026 · Presence of Particulate Matter: Hair was found in products
• Naropin recall (Fresenius Kabi USA, LLC)
  DrugClass IIReported July 29, 2026 · Presence of Particulate Matter: Hair was found in products
• Lidocaine HCl Injection recall (Fresenius Kabi USA, LLC)
  DrugClass IIReported July 29, 2026 · Presence of Particulate Matter: Hair was found in products
• Glycopyrrolate Injection recall (Fresenius Kabi USA, LLC)
  DrugClass IIReported July 29, 2026 · Presence of Particulate Matter: Hair was found in product
• Epinephrine Injection recall (Fresenius Kabi USA, LLC)
  DrugClass IIIReported June 17, 2026 · Failed Impurities/Degradations Specifications
• The Large Volume Pump recall (Fresenius Kabi USA, LLC)
  Medical deviceClass IIReported June 10, 2026 · Potential for the Cassette Loading Lever to break.
• Ivenix Infusion System recall (Fresenius Kabi USA, LLC)
  Medical deviceClass IReported June 10, 2026 · Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may...
• LVP software of the Ivenix Infusion System recall (Fresenius Kabi USA, LLC)
  Medical deviceClass IReported June 10, 2026 · Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut...
• 5% Dextrose Injection recall (Fresenius Kabi USA, LLC)
  DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility
• 5% Dextrose Injection recall (Fresenius Kabi USA, LLC)
  DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility
• 5% Dextrose Injection recall (Fresenius Kabi USA, LLC)
  DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility
• 0.9% Sodium Chloride Injection recall (Fresenius Kabi USA, LLC)
  DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility
• 0.9% Sodium Chloride Injection recall (Fresenius Kabi USA, LLC)
  DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility
• 0.9% Sodium Chloride Injection recall (Fresenius Kabi USA, LLC)
  DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility
• 0.9% Sodium Chloride Injection recall (Fresenius Kabi USA, LLC)
  DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility
• 0.9% Sodium Chloride Injection recall (Fresenius Kabi USA, LLC)
  DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility
• 0.9% Sodium Chloride Injection recall (Fresenius Kabi USA, LLC)
  DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility
• 0.9% Sodium Chloride Injection recall (Fresenius Kabi USA, LLC)
  DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility
• 0.9% Sodium Chloride Injection recall (Fresenius Kabi USA, LLC)
  DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility
• 0.9% Sodium Chloride Injection recall (Fresenius Kabi USA, LLC)
  DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility
• 0.9% Sodium Chloride Injection recall (Fresenius Kabi USA, LLC)
  DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility
• 0.45% Sodium Chloride Injection recall (Fresenius Kabi USA, LLC)
  DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility
• Ivenix Infusion System recall (Fresenius Kabi USA, LLC)
  Medical deviceClass IIReported January 21, 2026 · Emphasizing instructions for LVP duration programming located in the IFU.
• Ivenix Infusion System recall (Fresenius Kabi USA, LLC)
  Medical deviceClass IReported December 24, 2025 · Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.