Fresenius Kabi recalls
27 federal recalls on file, showing the 13 from the last 12 months. We read every CPSC, FDA, USDA and NHTSA notice for Fresenius Kabi and put it in plain English.
Recent recalls
Tyenne tocilizumab injection recalled for glass particlesFresenius Kabi USA discovered that Tyenne (tocilizumab-aazg) Injection vials may contain glass particles. The contamination was found during an internal investigation. The affected lot is 16UI07, which expires August 31, 2028.
SeriousFDASep 2, 2026
- Fresenius Kabi morphine syringes recalled for Dilaudid label mixup
Some Fresenius Kabi morphine sulfate prefilled syringes are labeled as morphine 2 mg/mL but actually contain Dilaudid (hydromorphone) 0.5 mg/0.5 mL. This labeling error could lead to patients receiving the wrong medication and dose. The affected lot is 6402820 with an expiration date of 12/2028.
SeriousFDAAug 26, 2026
Fresenius Kabi Tyenne injection recalled for glass particlesFresenius Kabi recalled one lot of Tyenne (tocilizumab-aazg) Injection 400 mg/20 mL vials after discovering the product contains glass particles. The affected lot was distributed nationwide to hospitals, clinics, and distributors.
SeriousFDAAug 10, 2026
Fresenius Kabi Morphine syringes recalled for wrong opioid in packagingFresenius Kabi recalled one lot of Morphine Sulfate Injection 2 mg/1 mL prefilled syringes due to a labeling error. Packages labeled as morphine may actually contain Dilaudid (hydromorphone), a different and more potent opioid. Using the wrong medication could cause serious respiratory problems or death, especially in patients not used to opioids or those with lung disease.
SeriousFDAAug 4, 2026
- Fresenius Kabi Xylocaine, Naropin and more recalled over hair
Fresenius Kabi is recalling five injectable medicine products because hair was found in some vials. The products are Xylocaine (two sizes), Naropin, lidocaine HCl injection and glycopyrrolate injection, all made by Fresenius Kabi in Lake Zurich, Illinois, and sold nationwide. No injuries have been reported.
ModerateFDAJul 29, 20265 products
- Fresenius Kabi epinephrine injection recalled for impurity concerns
Fresenius Kabi USA is recalling specific batches of epinephrine injection due to failed impurity and degradation specifications. The affected vials may not meet required purity standards. No injuries have been reported.
ModerateFDAJun 17, 2026
- Fresenius Kabi IV saline and dextrose bags recalled over sterility
Fresenius Kabi is recalling 14 sodium chloride and dextrose IV fluid bags because the company cannot assure they are sterile. The products were sold under the Fresenius Kabi, BD and Fresenius Medical Care names and were distributed nationwide, to Alaska and to Puerto Rico. No injuries have been reported.
ModerateFDAApr 15, 202614 products
- Fagron Sterile Services IV bags recalled over sterility concerns
Fresenius Kabi is recalling five premixed IV bags labeled Fagron Sterile Services in Canton, MA: acyclovir, ketamine, thiamine, and two strengths of vancomycin. The company cannot assure the bags are sterile. No injuries have been reported.
SeriousFDAFeb 18, 20265 products
Check Fresenius Kabi Ivenix Infusion System softwareFresenius Kabi is issuing a recall for the Ivenix Infusion System (IIS) with LVP Software version 5.10.2 and earlier. The manufacturer is emphasizing instructions for LVP duration programming in the device manual to ensure proper use. No injuries have been reported.
ModerateFDAJan 21, 2026
- Ivenix Infusion System software recalled for potential patient harm
Fresenius Kabi has recalled software version 5.10.1 and earlier for the Ivenix Infusion System due to anomalies that could cause serious patient harm. The affected software is used to control the delivery of fluids to patients in medical settings. About 30 units have been distributed across multiple U.S. states.
SeriousFDADec 24, 2025
- Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
FDADec 10, 2025
- IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
FDADec 10, 2025
- Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
FDADec 3, 2025