Fresenius Kabi USA, LLC
Complete recall history across all FDA and CPSC categories — 67 total recalls
Recall Summary
Fresenius Kabi USA, LLC appears in recall records across 2 categories. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (45)
FDA drug safety enforcement actions by Fresenius Kabi USA, LLC
| Date | Product | Reason | Class |
|---|---|---|---|
| Nov 6, 2025 | Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only... | Microbial Contamination of Sterile Products; out of limit results obtained fo... | Class I |
| Nov 22, 2022 | Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine... | Subpotent Drug: Testing results below the defined limit for the epinephrine p... | Class II |
| Nov 22, 2022 | Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epineph... | Subpotent Drug: Testing results below the defined limit for the epinephrine p... | Class II |
| Nov 22, 2022 | Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine... | Subpotent Drug: Testing results below the defined limit for the epinephrine p... | Class II |
| Mar 4, 2022 | Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 t... | Presence of particulate matter: particulates composed of carbon and oxygen wi... | Class I |
| Dec 23, 2020 | Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single ... | Presence of Particulate Matter - found in reserve sample vials at the firm. | Class I |
| Dec 17, 2020 | Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), package... | Presence of Particulate Matter - found in reserve sample vials at the firm. | Class II |
| Dec 10, 2020 | Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 m... | Subpotent Drug: Low out-of-specification assay results for the epinephrine co... | Class II |
| Nov 17, 2020 | Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg... | Cross Contamination with other products: trace amounts of lidocaine | Class I |
| Nov 17, 2020 | DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill... | Cross Contamination with Other Products: trace amounts of octreotide found du... | Class III |
| Jul 22, 2020 | Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 m... | Cross Contamination with other products: trace amounts of lidocaine | Class I |
| Jul 13, 2020 | Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx on... | Labeling Error: Label Error on Declared Strength: Carton label and product in... | Class III |
| Apr 20, 2020 | Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), package... | Presence of Particulate Matter - found in reserve sample vials at the firm. | Class II |
| Apr 20, 2020 | Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single ... | Presence of Particulate Matter - found in reserve sample vials at the firm. | Class I |
| Jun 28, 2019 | Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 ... | Presence of Particulate Matter; glass particulates | Class I |
| May 22, 2019 | Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kab... | Failed Impurities/Degradation Specifications. | Class III |
| Nov 15, 2018 | SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 2... | Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due t... | Class I |
| Nov 15, 2018 | SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 2... | Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due t... | Class I |
| Jan 16, 2018 | Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius K... | Failed impurities/ degradation specifications: Out-of-specification (OOS) res... | Class III |
| Oct 27, 2017 | Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2m... | Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, US... | Class I |
| Mar 16, 2017 | Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Phar... | Subpotent Drug | Class III |
| Dec 16, 2016 | MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per c... | Failed Impurities/Degradation Specifications | Class II |
| May 4, 2016 | OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose... | Failed Impuities/Degradation Specifications | Class II |
| May 4, 2016 | OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose... | Failed Impuities/Degradation Specifications | Class II |
| Apr 25, 2016 | Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Do... | Presence of Particulate Matter: Glass particulate found in sterile injectable... | Class II |
| Apr 7, 2016 | Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi... | Failed Impurities/Degradation Specifications: Firm is recalling product due t... | Class III |
| Apr 5, 2016 | Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intraven... | Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrec... | Class II |
| Jul 28, 2015 | Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; sin... | Incorrect Expiration Date: The "11/06" expiration date printed on the tray (s... | Class III |
| Jun 4, 2015 | Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured ... | Failed Impurities/Degradation Specifications; out-of-specification for color,... | Class II |
| Apr 28, 2015 | KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electro... | Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but cont... | Class II |
| Nov 12, 2014 | GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Do... | Defective Container: Vials may be missing stoppers. | Class II |
| Aug 13, 2014 | PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx o... | CGMP Deviations: Citations given to API supplier by the Italian Health Agency... | Class II |
| May 2, 2014 | Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= pheny... | Presence of Particular Matter: Potential glass delamination and consistent wi... | Class II |
| May 2, 2014 | Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenyto... | Presence of Particular Matter: Potential glass delamination and consistent wi... | Class II |
| Jan 22, 2014 | Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per... | Subpotent; 18 month time point | Class II |
| Dec 6, 2013 | FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Do... | Failed Impurities/Degradation specifications: out-of-specification results 14... | Class III |
| Nov 8, 2013 | PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple ... | Labeling: Incorrect or Missing Package Insert- Missing text on the product in... | Class III |
| Oct 31, 2013 | Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fres... | Presence of Particulate Matter: Particulate matter consistent with delaminati... | Class II |
| Jul 1, 2013 | Benztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/1 mL), 2 mL Single Dose ... | Presence of particulate matter: characterized as thin colorless flakes that ... | Class II |
| Jun 24, 2013 | Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM ... | Subpotent Drug; 15-month stability test station | Class II |
| May 25, 2013 | Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 ... | Presence of Particulate Matter: Glass particulate matter was observed in a re... | Class I |
| May 21, 2013 | Folic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dos... | Failed Impurities/Degradation Specification | Class III |
| Sep 27, 2012 | ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single D... | Lack of Assurance of Sterility: Glass vials may have finish fractures and gla... | Class II |
| Sep 27, 2012 | MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vi... | Lack of Assurance of Sterility: Glass vials may have finish fractures and gla... | Class II |
| Sep 27, 2012 | CYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, For IM or IV Use, Multiple Dose 2... | Lack of Assurance of Sterility: Glass vials may have finish fractures and gla... | Class II |
Device Recalls (22)
FDA medical device enforcement actions by Fresenius Kabi USA, LLC
| Date | Product | Reason | Class |
|---|---|---|---|
| Nov 21, 2025 | Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005. | Emphasizing instructions for LVP duration programming located in the IFU. | Class II |
| Nov 14, 2025 | Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the cont... | Software version 5.10.1 and earlier contain anomalies that have the potential... | Class I |
| Nov 3, 2025 | IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbi... | Incorrect assembly of specific lot of LVP Primary Administration Set that cou... | Class I |
| Nov 3, 2025 | Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. | Downstream Occlusion alarms may occur during procedures using low flow infusi... | Class II |
| Sep 3, 2025 | Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. | Potential issue that can cause the device to register "phantom" touches in th... | Class II |
| Jun 24, 2025 | LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh F... | Potential for external cassette leaks | Class II |
| Jun 24, 2025 | LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product C... | Potential for external cassette leaks | Class II |
| Jun 24, 2025 | LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-... | Potential for external cassette leaks | Class II |
| Jun 24, 2025 | LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Du... | Potential for external cassette leaks | Class II |
| May 12, 2025 | IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low... | Mis-assembly error of Blood Products Administrations Sets where the 200-micro... | Class I |
| Jan 10, 2025 | Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use ... | Large Volume Pump Software, version 5.9.2 and earlier has potential for the f... | Class I |
| Dec 6, 2024 | Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 | Potential pneumatic valve failure that may cause the LVP to stop an active in... | Class I |
| Aug 30, 2024 | Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9... | The software has anomalies that have the potential to cause alarms, nonfuncti... | Class I |
| Aug 1, 2024 | LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-... | A defect may cause an uncontrolled medication flow condition which may result... | Class I |
| Mar 7, 2024 | LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0. | Software has anomalies that have the potential to cause underdose, overdose, ... | Class I |
| Nov 29, 2023 | Ivenix Infusion System (IIS), Large Volume Pump LVP-0004 | The device may experience mechanical interference on the Fluid Valve pins, wh... | Class I |
| May 10, 2023 | LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004 | Retroactively reported corrections from 2023: 1) A software defect may cause ... | Class II |
| Mar 10, 2023 | Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004 | Fluid ingress that can cause a loss of electrical funtion and failure of the ... | Class I |
| Sep 16, 2022 | LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004 | Retroactively reported correction from 2022: A software defect may cause an i... | Class II |
| Sep 8, 2022 | Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0 | The display screen may become frozen and unresponsive to user input, triggeri... | Class I |
| Apr 22, 2022 | Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0... | Start-up time for the flow rate range greater than 50 ml/hr, and less than 20... | Class II |
| Dec 19, 2014 | HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 US... | The lot failed pH specification. | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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