PlainRecalls

Fresenius Kabi USA, LLC

Compiled from official public sources by the publisher.

93 recalls on record · Latest: Jul 29, 2026

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Agency notice ledger

Federal filing book Fresenius Kabi USA, LLC MID-BOOK · MULTI-AGENCY

#179 of 14,151 · 93 notices · 0.089% archive

  • BOOK 93 notices
  • RANK #179 of 14,151
  • SHARE 0.089% archive
  • AGENCY FDA Drug (68)
  • CAT drugs
  • CATS 2 categories
  • LATEST Jul 29, 2026
  • PHOTO Harris Teeter

Nearest notice-volume peer: Harris Teeter (0 notice gap)

Fresenius Kabi USA, LLC accounts for about 0.089% of the 104,423-notice archive on 93 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Fresenius Kabi USA, LLC's standing among 14,151 recalling firms

Fresenius Kabi USA, LLC ranks 179th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Fresenius Kabi USA, LLC vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

93 179th of 14151 higher than 13,969 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Fresenius Kabi USA, LLC in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Fresenius Kabi USA, LLC holds about 0.089% of archive notices alongside 93 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026

How the 93 notices break down

Same federal filing book as the hero total — split by issuing agency, no new counts.

FDA Drug Moderate Jul 29, 2026

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 NDC Tray: 63323-286-23; NDC Vial: 63323-286-05
FDA Drug Moderate Jul 29, 2026

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: 63323-485-27; NDC Vial: 63323-485-01
FDA Drug Moderate Jul 29, 2026

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: 63323-208-05; NDC Vial: 63323-208-01
FDA Drug Moderate Jul 29, 2026

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: 63323-485-57; NDC Vial: 63323-485-03
FDA Drug Moderate Jul 29, 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, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-578-05; NDC Vial: 63323-578-07
FDA Drug Low Jun 17, 2026

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)
FDA Devices Moderate Jun 10, 2026

The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
FDA Devices Critical Jun 10, 2026

LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
FDA Devices Critical Jun 10, 2026

Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
FDA Drug Moderate Apr 15, 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 only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-470-05, Unit of Sale NDC Number: 65219-470-30.
FDA Drug Moderate Apr 15, 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 bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case).
FDA Drug Moderate Apr 15, 2026

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"), IL 60047, Unit of Use NDC: 65219-432-20, Unit of Sale NDC Number: 65219-432-85.
FDA Drug Moderate Apr 15, 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, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 600047, Unit of Use NDC: 65219-468-05, Unit of Sale NDC Number: 65219-468-50.
FDA Drug Moderate Apr 15, 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 only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20.
FDA Drug Moderate Apr 15, 2026

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 Lakes, NJ 07417 USA, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-03.
FDA Drug Moderate Apr 15, 2026

5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-456-05, Unit of Sale NDC Number: 65219-456-60.
FDA Drug Moderate Apr 15, 2026

5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-458-05, Unit of Sale NDC Number: 65219-458-30.
FDA Drug Moderate Apr 15, 2026

5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-464-05, Unit of Sale NDC Number: 65219-464-50.
FDA Drug Moderate Apr 15, 2026

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 by: Fresenius Medical Care RTG, LLC, Manufactured by: Fresenius Kabi, Unit of Use NDC: 65219-282-01, Unit of Sale NDC Number: 65219-282-10.
FDA Drug Moderate Apr 15, 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, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-466-05, Unit of Sale NDC Number: 65219-466-60.
FDA Drug Moderate Apr 15, 2026

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, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-02.
FDA Drug Moderate Apr 15, 2026

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 Lakes, NJ 07417, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-05.
FDA Drug Moderate Apr 15, 2026

0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by Fresenius Kabi, Unit of Sale NDC Number: 17271-701-07.
FDA Devices Moderate Jan 21, 2026

Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
FDA Devices Critical Dec 24, 2025

Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
FDA Devices Moderate Dec 10, 2025

Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
FDA Devices Critical Dec 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.
FDA Drug Critical Dec 3, 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).
FDA Devices Moderate Nov 5, 2025

Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
FDA Devices Moderate Aug 6, 2025

LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
FDA Devices Moderate Aug 6, 2025

LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
FDA Devices Moderate Aug 6, 2025

LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.
FDA Devices Moderate Aug 6, 2025

LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.
FDA Devices Critical Jun 18, 2025

IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
FDA Devices Critical Feb 12, 2025

Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.
FDA Devices Critical Jan 15, 2025

Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
FDA Devices Critical Oct 2, 2024

Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
FDA Devices Critical Sep 11, 2024

LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.
FDA Devices Critical Apr 17, 2024

LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
FDA Devices Moderate Mar 20, 2024

LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
FDA Devices Moderate Mar 20, 2024

LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
FDA Devices Critical Dec 27, 2023

Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
FDA Devices Moderate Oct 4, 2023

Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.
FDA Devices Critical Apr 19, 2023

Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
FDA Drug Moderate Jan 25, 2023

Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-463-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-463-57), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
FDA Drug Moderate Jan 25, 2023

Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mg per 10 mL (2.5 mg per mL), 10 mL Single Dose Vial (NDC 63323-468-01), packaged in 25 Single Dose Vials per tray (NDC 63323-468-17), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
FDA Drug Moderate Jan 25, 2023

Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg per 50 mL (2.5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-461-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-461-57), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
FDA Devices Critical Oct 12, 2022

Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
FDA Drug Critical Mar 30, 2022

Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC 63323-032-00), each vial: 100 mL fill in a 100 mL vial (NDC 63323-032-04), Rx Only, Fresenius Kabi, Lake Zurich, IL 60047
FDA Drug Moderate Oct 6, 2021

Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01. 25 vials per tray packaged 18 trays per shipper

Fresenius Kabi USA, LLC carries an outsized archive share

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar drugs volume

Nearest multi-notice firms that share this firm's dominant product category.

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Frequently Asked Questions

How many federal recall notices name Fresenius Kabi USA, LLC? ▼
PlainRecalls indexes 93 distinct federal recall events naming Fresenius Kabi USA, LLC, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Fresenius Kabi USA, LLC sit among other recalling firms? ▼
Fresenius Kabi USA, LLC ranks #179 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Fresenius Kabi USA, LLC's notices? ▼
FDA Drug accounts for 68 of this firm's 93 indexed notices across 2 issuing agencies.
What product category dominates Fresenius Kabi USA, LLC's filing book? ▼
Filings for Fresenius Kabi USA, LLC span 2 product categories, led by drugs. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Fresenius Kabi USA, LLC: 93 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Drug). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Fresenius Kabi USA, LLC; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026