Fresenius Kabi USA, LLC recalls

All Fresenius Kabi USA, LLC recalls we track from FDA, CPSC and NHTSA data. Categories: drugs (23), medical devices (15).

38 recalls published between January 15, 2025 and September 2, 2026. Most common issues: sterility (15), software (3), injury risk (1), microbial contamination (1). 10 were FDA Class I, the most serious level.

• Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial… recall
  FDA September 2, 2026 · Fresenius Kabi USA, LLC · Class I
• Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist… recall
  FDA August 26, 2026 · Fresenius Kabi USA, LLC · Class I
• Xylocaine (lidocaine HCl Injection, USP), 1%… recall
  FDA July 29, 2026 · Fresenius Kabi USA, LLC · Class II
• Xylocaine (lidocaine HCl Injection, USP), 1%… recall
  FDA July 29, 2026 · Fresenius Kabi USA, LLC · Class II
• Naropin (ropivacaine hydrochloride Injection, USP), 0.5%… recall
  FDA July 29, 2026 · Fresenius Kabi USA, LLC · Class II
• Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL)… recall
  FDA July 29, 2026 · Fresenius Kabi USA, LLC · Class II
• Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL)… recall
  FDA July 29, 2026 · Fresenius Kabi USA, LLC · Class II
• Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only… recall
  FDA June 17, 2026 · Fresenius Kabi USA, LLC · Class III
• The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS) recall
  FDA June 10, 2026 · Fresenius Kabi USA, LLC · Class II
• Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 recall
  FDA June 10, 2026 · Fresenius Kabi USA, LLC · Class I
• LVP software of the Ivenix Infusion System (IIS) recall
  FDA June 10, 2026 · Fresenius Kabi USA, LLC · Class I
• 5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a… recall
  FDA April 15, 2026 · Fresenius Kabi USA, LLC · Class II
• 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100… recall
  FDA April 15, 2026 · Fresenius Kabi USA, LLC · Class II
• 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100… recall
  FDA April 15, 2026 · Fresenius Kabi USA, LLC · Class II
• 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL)… recall
  FDA April 15, 2026 · Fresenius Kabi USA, LLC · Class II
• 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000… recall
  FDA April 15, 2026 · Fresenius Kabi USA, LLC · Class II
• 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL… recall
  FDA April 15, 2026 · Fresenius Kabi USA, LLC · Class II
• 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250… recall
  FDA April 15, 2026 · Fresenius Kabi USA, LLC · Class II
• 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100… recall
  FDA April 15, 2026 · Fresenius Kabi USA, LLC · Class II
• 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton… recall
  FDA April 15, 2026 · Fresenius Kabi USA, LLC · Class II
• 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL)… recall
  FDA April 15, 2026 · Fresenius Kabi USA, LLC · Class II
• 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL)… recall
  FDA April 15, 2026 · Fresenius Kabi USA, LLC · Class II
• 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per… recall
  FDA April 15, 2026 · Fresenius Kabi USA, LLC · Class II
• 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL)… recall
  FDA April 15, 2026 · Fresenius Kabi USA, LLC · Class II
• 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per… recall
  FDA April 15, 2026 · Fresenius Kabi USA, LLC · Class II
• Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005 recall
  FDA January 21, 2026 · Fresenius Kabi USA, LLC · Class II
• Ivenix Infusion System (IIS), LVP Software LVP-SW-0005… recall
  FDA December 24, 2025 · Fresenius Kabi USA, LLC · Class I
• Ivenix Infusion System (IIS), Large Volume Pump recall
  FDA December 10, 2025 · Fresenius Kabi USA, LLC · Class II
• IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet… recall
  FDA December 10, 2025 · Fresenius Kabi USA, LLC · Class I
• Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials… recall
  FDA December 3, 2025 · Fresenius Kabi USA, LLC · Class I
• Ivenix Infusion System (IIS), Large Volume Pump recall
  FDA November 5, 2025 · Fresenius Kabi USA, LLC · Class II
• LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port… recall
  FDA August 6, 2025 · Fresenius Kabi USA, LLC · Class II
• LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25) recall
  FDA August 6, 2025 · Fresenius Kabi USA, LLC · Class II
• LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site… recall
  FDA August 6, 2025 · Fresenius Kabi USA, LLC · Class II
• LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port… recall
  FDA August 6, 2025 · Fresenius Kabi USA, LLC · Class II
• IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet… recall
  FDA June 18, 2025 · Fresenius Kabi USA, LLC · Class I
• Ivenix Infusion System (IIS), LVP Software LVP-SW-0005… recall
  FDA February 12, 2025 · Fresenius Kabi USA, LLC · Class I
• Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 recall
  FDA January 15, 2025 · Fresenius Kabi USA, LLC · Class I