Fresenius Kabi USA, LLC recalls
67 recalls in our records from 2013 to 2026: 45 FDA drugs, 22 FDA medical devices.
Recalls with full detail pages
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Fresenius Kabi USA, LLC drug recall: Tyenne
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
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Fresenius Kabi USA, LLC drug recall: Morphine Sulfate Injection
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
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Fresenius Kabi USA, LLC medical device recall: Ivenix Infusion System
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 not be…
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Fresenius Kabi USA, LLC medical device recall: LVP software of the Ivenix Infusion System
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 down the…
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Fresenius Kabi USA, LLC medical device recall: Ivenix Infusion System
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
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Fresenius Kabi USA, LLC medical device recall: Ivenix Infusion System
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
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Fresenius Kabi USA, LLC drug recall: Famotidine Injection
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
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Fresenius Kabi USA, LLC medical device recall: IVENIX INFUSION SYSTEM LVP Blood Products Administration Set
Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood…
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Fresenius Kabi USA, LLC medical device recall: Ivenix Infusion System
Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the…
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Fresenius Kabi USA, LLC medical device recall: Ivenix Infusion System
Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.
Earlier and other recalls
These link to the official agency notice.
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Fresenius Kabi USA, LLC drug recall: Glycopyrrolate Injection Official notice ↗
Presence of Particulate Matter: Hair was found in product
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Fresenius Kabi USA, LLC drug recall: Epinephrine Injection Official notice ↗
Failed Impurities/Degradations Specifications
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Fresenius Kabi USA, LLC medical device recall: The Large Volume Pump Official notice ↗
Potential for the Cassette Loading Lever to break.
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Fresenius Kabi USA, LLC drug recall: 0.45% Sodium Chloride Injection Official notice ↗
Lack of Assurance of Sterility
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Fresenius Kabi USA, LLC medical device recall: Ivenix Infusion System Official notice ↗
Emphasizing instructions for LVP duration programming located in the IFU.
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Fresenius Kabi USA, LLC medical device recall: Ivenix Infusion System Official notice ↗
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
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Fresenius Kabi USA, LLC medical device recall: Ivenix Infusion System Official notice ↗
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
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Fresenius Kabi USA, LLC medical device recall: LVP Primary Administration Set Official notice ↗
Potential for external cassette leaks
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Fresenius Kabi USA, LLC medical device recall: Ivenix Infusion System Official notice ↗
The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious…
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Fresenius Kabi USA, LLC medical device recall: LVP Primary Administration Set Official notice ↗
A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose).
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Fresenius Kabi USA, LLC medical device recall: LVP Software of the Ivenix Infusion System Official notice ↗
Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
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Fresenius Kabi USA, LLC medical device recall: LVP software of the Ivenix Infusion System Official notice ↗
Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the…
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Fresenius Kabi USA, LLC medical device recall: LVP software of the Ivenix Infusion System Official notice ↗
Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion…
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Fresenius Kabi USA, LLC medical device recall: Ivenix Infusion System Official notice ↗
The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of…
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Fresenius Kabi USA, LLC medical device recall: Ivenix Infusion System Official notice ↗
Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble…
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Fresenius Kabi USA, LLC medical device recall: Ivenix Infusion System Official notice ↗
Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion.
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Fresenius Kabi USA, LLC drug recall: Sensorcaine Official notice ↗
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
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Fresenius Kabi USA, LLC medical device recall: Ivenix Infusion System Official notice ↗
The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary…
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Fresenius Kabi USA, LLC drug recall: Sodium Acetate Injection Official notice ↗
Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and…
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Fresenius Kabi USA LLC drug recall: Morphine Sulfate Injection Official notice ↗
Defective container: Cracked vials leading to lack of sterility assurance
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Fresenius Kabi USA LLC drug recall: Xylocaine-MPF with Epinephrine 1:200 Official notice ↗
Low out of specification results for epinephrine assay.
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Fresenius Kabi USA, LLC drug recall: Ketorolac Tromethamine Injection Official notice ↗
Presence of Particulate Matter - found in reserve sample vials at the firm.
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Fresenius Kabi USA, LLC drug recall: Ketorolac Tromethamine Injection Official notice ↗
Presence of Particulate Matter - found in reserve sample vials at the firm.
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Fresenius Kabi USA, LLC drug recall: Sensorcaine-MPF Official notice ↗
Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
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Fresenius Kabi USA, LLC drug recall: Dexmedetomidine HCl in 0.9% Sodium Chloride Injection Official notice ↗
Cross Contamination with other products: trace amounts of lidocaine
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Fresenius Kabi USA, LLC drug recall: DOXOrubicin Hydrochloride Injection Official notice ↗
Cross Contamination with Other Products: trace amounts of octreotide found during testing
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Fresenius Kabi USA, LLC drug recall: Dexmedetomidine HCl in 0.9% Sodium Chloride Injection Official notice ↗
Cross Contamination with other products: trace amounts of lidocaine
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Fresenius Kabi USA, LLC drug recall: Fosaprepitant for Injection Official notice ↗
Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg /…
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Fresenius Kabi USA, LLC drug recall: Ketorolac Tromethamine Injection Official notice ↗
Presence of Particulate Matter - found in reserve sample vials at the firm.
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Fresenius Kabi USA, LLC drug recall: Fluorouracil Injection Official notice ↗
Presence of Particulate Matter; glass particulates
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Fresenius Kabi USA, LLC drug recall: Ondansetron Injection Official notice ↗
Failed Impurities/Degradation Specifications.
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Fresenius Kabi USA, LLC drug recall: Sodium Chloride Injection Official notice ↗
Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620…
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Fresenius Kabi USA, LLC drug recall: Vecuronium bromide for Injection Official notice ↗
Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.
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Fresenius Kabi USA, LLC drug recall: Midazolam Injection Official notice ↗
Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL
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Fresenius Kabi USA, LLC drug recall: Fluphenazine Decanoate Injection Official notice ↗
Subpotent Drug
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Fresenius Kabi USA, LLC drug recall: Midazolam Injection Official notice ↗
Failed Impurities/Degradation Specifications
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Fresenius Kabi USA, LLC drug recall: Sensorcaine- MPF Official notice ↗
Presence of Particulate Matter: Glass particulate found in sterile injectable product
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Fresenius Kabi USA, LLC drug recall: Octreotide Acetate Injection Official notice ↗
Failed Impuities/Degradation Specifications
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Fresenius Kabi USA, LLC drug recall: Cisatracurium Besylate Injection Official notice ↗
Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer…
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Fresenius Kabi USA, LLC drug recall: Haloperidol Decanoate Injection Official notice ↗
Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
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Fresenius Kabi USA, LLC drug recall: Hydralazine Hydrochloride Injection Official notice ↗
Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)
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Fresenius Kabi USA, LLC drug recall: Rifampin for Injection Official notice ↗
Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation
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Fresenius Kabi USA, LLC drug recall: KABIVEN [(3.9%) Lipid Injectable Emulsion with Official notice ↗
Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids
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Fresenius Kabi USA, LLC medical device recall: Hepflush-10 Official notice ↗
The lot failed pH specification.
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Fresenius Kabi USA, LLC drug recall: Gentamicin Injection Official notice ↗
Defective Container: Vials may be missing stoppers.
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Fresenius Kabi USA, LLC drug recall: Midazolam Hydrochloride Injection Official notice ↗
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
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Fresenius Kabi USA LLC drug recall: Haloperidol Decanoate Injection Official notice ↗
Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.
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Fresenius Kabi USA, LLC drug recall: Propranolol Hydrochloride Injection Official notice ↗
CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to…
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Fresenius Kabi USA, LLC drug recall: Fosphenytoin Sodium Injection Official notice ↗
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
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Fresenius Kabi USA, LLC drug recall: Heparin Sodium Injection Official notice ↗
Subpotent; 18 month time point
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Fresenius Kabi USA, LLC drug recall: Tranexamic Acid Injection USP Official notice ↗
Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container.
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Fresenius Kabi USA, LLC drug recall: Folic Acid Injection Official notice ↗
Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
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Fresenius Kabi USA, LLC drug recall: Paclitaxel Injection Official notice ↗
Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
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Fresenius Kabi USA, LLC drug recall: Magnesium Sulfate Injection Official notice ↗
Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.
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Fresenius Kabi USA, LLC drug recall: Oxytocin Injection Official notice ↗
Subpotent Drug; 15-month stability test station
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Fresenius Kabi USA, LLC drug recall: Benztropine Mesylate Injection Official notice ↗
Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample…
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Fresenius Kabi USA, LLC drug recall: Folic Acid Injection Official notice ↗
Failed Impurities/Degradation Specification
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.