--- title: "Fresenius Kabi USA, LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Fresenius Kabi USA, LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/fresenius-kabi-usa-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Fresenius Kabi USA, LLC recall records **44** reported ongoing 52 records in this archive. Latest source date Aug 10, 2026. 1 published notices do not supply a closure status. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Aug 10, 2026 FDA drug enforcement ### [Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Illinois, 60047, NDC 65219-594-20.](https://isitonrecall.com/recall/fda-drug-d-0827-2026-tyenne-tocilizumab-aazg-injection-400-mg-20-ml-20-mg-ml-20-ml-vial-rx-only-manufactured-by-fresenius/) Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles. Class I Reported ongoing Distribution: Nationwide in the USA [Official source for Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured b...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0827-2026%22) Aug 4, 2026 FDA drug enforcement ### [Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake Zurich, IL. Unit of ...](https://isitonrecall.com/recall/fda-drug-d-0788-2026-morphine-sulfate-injection-usp-2-mg-ml-1-ml-single-dose-simplist-prefilled-syringes-for-intramuscula/) Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL. Class I Reported ongoing Distribution: Nationwide within the USA. [Official source for Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intr...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0788-2026%22) Jul 16, 2026 FDA drug enforcement ### [Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 6332...](https://isitonrecall.com/recall/fda-drug-d-0725-2026-glycopyrrolate-injection-usp-1-mg-per-5-ml-0-2-mg-per-ml-25-x-5-ml-fill-in-a-6-5-ml-vial-rx-only-mul/) Presence of Particulate Matter: Hair was found in product Class II Reported ongoing Distribution: Nationwide within in the USA [Official source for Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0725-2026%22) Jul 16, 2026 FDA drug enforcement ### [Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-20...](https://isitonrecall.com/recall/fda-drug-d-0726-2026-lidocaine-hcl-injection-usp-2-100-mg-per-5-ml-20-mg-per-ml-25-single-dose-vials-5-ml-per-vial-rx-onl/) Presence of Particulate Matter: Hair was found in products Class II Reported ongoing Distribution: Nationwide within in the USA [Official source for Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0726-2026%22) Jul 16, 2026 FDA drug enforcement ### [Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 ND...](https://isitonrecall.com/recall/fda-drug-d-0727-2026-naropin-ropivacaine-hydrochloride-injection-usp-0-5-100-mg-per-20-ml-5-mg-per-ml-twenty-five-20-ml-s/) Presence of Particulate Matter: Hair was found in products Class II Reported ongoing Distribution: Nationwide within in the USA [Official source for Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0727-2026%22) Jul 16, 2026 FDA drug enforcement ### [Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 6...](https://isitonrecall.com/recall/fda-drug-d-0728-2026-xylocaine-lidocaine-hcl-injection-usp-1-200-mg-per-20-ml-10-mg-per-ml-25-multiple-dose-vials-20-ml-r/) Presence of Particulate Matter: Hair was found in products Class II Reported ongoing Distribution: Nationwide within in the USA [Official source for Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose V...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0728-2026%22) Jul 16, 2026 FDA drug enforcement ### [Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 6...](https://isitonrecall.com/recall/fda-drug-d-0729-2026-xylocaine-lidocaine-hcl-injection-usp-1-500-mg-per-50-ml-10-mg-per-ml-25-multiple-dose-vials-50-ml-r/) Presence of Particulate Matter: Hair was found in products Class II Reported ongoing Distribution: Nationwide within in the USA [Official source for Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose V...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0729-2026%22) May 14, 2026 FDA drug enforcement ### [Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)](https://isitonrecall.com/recall/fda-drug-d-0581-2026-epinephrine-injection-usp-1mg-ml-1-ml-single-dose-vial-rx-only-fresenius-kabi-lake-zurich-il-60047-n/) Failed Impurities/Degradations Specifications Class III Reported ongoing Distribution: US Nationwide. [Official source for Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0581-2026%22) May 6, 2026 FDA device enforcement ### [LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.](https://isitonrecall.com/recall/fda-device-z-2223-2026-lvp-software-of-the-ivenix-infusion-system-iis-product-code-lvp-sw-0005/) 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 pump unless it is reconnected to AC mains power. Class I Reported ongoing Distribution: US Nationwide distribution in the states of CA, CO, FL, GA, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI. [Official source for LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2223-2026%22) May 6, 2026 FDA device enforcement ### [Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004](https://isitonrecall.com/recall/fda-device-z-2224-2026-ivenix-infusion-system-iis-large-volume-pump-model-number-lvp-0004/) 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 apparent or readily visible and the devices therefore remained in service. More specifically... Class I Reported ongoing Distribution: Domestic: CA, CO, FL, GA, ID, IL, MD, MI, MI , MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI; [Official source for Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2224-2026%22) Mar 11, 2026 FDA drug enforcement ### [0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, ...](https://isitonrecall.com/recall/fda-drug-d-0424-2026-0-45-sodium-chloride-injection-usp-1-125-grams-per-250-ml-4-5-mg-per-ml-250-ml-in-a-250-ml-freeflex/) Lack of Assurance of Sterility Class II Reported ongoing Distribution: US Nationwide , Alaska, and Puerto Rico. [Official source for 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0424-2026%22) Mar 11, 2026 FDA drug enforcement ### [0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 652...](https://isitonrecall.com/recall/fda-drug-d-0425-2026-0-9-sodium-chloride-injection-usp-0-9-450-mg-per-50-ml-9-mg-per-ml-50-ml-rx-only-fresenius-kabi-usa/) Lack of Assurance of Sterility Class II Reported ongoing Distribution: US Nationwide , Alaska, and Puerto Rico. [Official source for 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Freseni...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0425-2026%22) Mar 11, 2026 FDA drug enforcement ### [0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL...](https://isitonrecall.com/recall/fda-drug-d-0426-2026-0-9-sodium-chloride-injection-usp-0-9-900-mg-per-100-ml-9-mg-per-ml-100-ml-in-a-100-ml-freeflex-bag/) Lack of Assurance of Sterility Class II Reported ongoing Distribution: US Nationwide , Alaska, and Puerto Rico. [Official source for 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL fr...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0426-2026%22) Mar 11, 2026 FDA drug enforcement ### [0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60...](https://isitonrecall.com/recall/fda-drug-d-0427-2026-0-9-sodium-chloride-injection-usp-2-250-mg-per-250-ml-9-mg-per-ml-250-ml-in-a-250-ml-freeflex-bag-rx/) Lack of Assurance of Sterility Class II Reported ongoing Distribution: US Nationwide , Alaska, and Puerto Rico. [Official source for 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freef...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0427-2026%22) Mar 11, 2026 FDA drug enforcement ### [0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60...](https://isitonrecall.com/recall/fda-drug-d-0428-2026-0-9-sodium-chloride-injection-usp-4-500-mg-per-500-ml-9-mg-per-ml-500-ml-in-a-500-ml-freeflex-bag-rx/) Lack of Assurance of Sterility Class II Reported ongoing Distribution: US Nationwide , Alaska, and Puerto Rico. [Official source for 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freef...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0428-2026%22) Mar 11, 2026 FDA drug enforcement ### [0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA...](https://isitonrecall.com/recall/fda-drug-d-0429-2026-0-9-sodium-chloride-injection-usp-50-ml-x60-becton-dickson-and-company-1-beckton-drive-franklin-lake/) Lack of Assurance of Sterility Class II Reported ongoing Distribution: US Nationwide , Alaska, and Puerto Rico. [Official source for 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Fra...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0429-2026%22) Mar 11, 2026 FDA drug enforcement ### [0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin La...](https://isitonrecall.com/recall/fda-drug-d-0430-2026-0-9-sodium-chloride-injection-usp-900-mg-per-100-ml-9-mg-per-ml-100-ml-in-a-single-dose-freeflex-bag/) Lack of Assurance of Sterility Class II Reported ongoing Distribution: US Nationwide , Alaska, and Puerto Rico. [Official source for 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose free...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0430-2026%22) Mar 11, 2026 FDA drug enforcement ### [0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Beckton Drive, Franklin Lak...](https://isitonrecall.com/recall/fda-drug-d-0431-2026-0-9-sodium-chloride-injection-usp-900-mg-per-100-ml-9-mg-per-ml-250-ml-in-a-single-dose-freeflex-bag/) Lack of Assurance of Sterility Class II Reported ongoing Distribution: US Nationwide , Alaska, and Puerto Rico. [Official source for 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose free...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0431-2026%22) Mar 11, 2026 FDA drug enforcement ### [0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi...](https://isitonrecall.com/recall/fda-drug-d-0432-2026-0-9-sodium-chloride-injection-usp-900-mg-per-100-ml-9-mg-per-ml-500-ml-in-a-single-dose-freeflex-bag/) Lack of Assurance of Sterility Class II Reported ongoing Distribution: US Nationwide , Alaska, and Puerto Rico. [Official source for 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freef...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0432-2026%22) Mar 11, 2026 FDA drug enforcement ### [0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed ...](https://isitonrecall.com/recall/fda-drug-d-0433-2026-0-9-sodium-chloride-injection-usp-900-mg-per-100-ml-9-mg-per-ml-1-000-ml-in-a-single-dose-freeflex-b/) Lack of Assurance of Sterility Class II Reported ongoing Distribution: US Nationwide , Alaska, and Puerto Rico. [Official source for 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose fr...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0433-2026%22) ## Reasons in these listed records - Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles. - Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL. - Presence of Particulate Matter: Hair was found in product - Presence of Particulate Matter: Hair was found in products These examples come from this result page and are not a ranking of every recall reason. ## Checking Fresenius Kabi USA, LLC ### Is there a recall on fresenius kabi usa, llc right now? This archive contains 52 records, including 44 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Fresenius Kabi USA, LLC](https://isitonrecall.com/check/?q=Fresenius%20Kabi%20USA%2C%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)