Food, drugs, devices › Fresenius Kabi USA, LLC

Drug recall: Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton,

FDA enforcement event 78396 · Class I · initiated 27 Oct 2017 · status Terminated · terminated 5 Oct 2020

DrugVoluntary: Firm initiated1 product recordWilson, NC

Fresenius Kabi USA, LLC (Wilson, NC) initiated this drug recall on 27 Oct 2017; FDA lists 1 product record under event 78396, classified Class I.

FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 13% of the 343 drug enforcement events initiated in 2017 carry the same class.

Status: Terminated, terminated 5 Oct 2020. Initiation: voluntary: firm initiated. Fresenius Kabi USA, LLC has 67 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Fresenius Kabi USA, LLC, Wilson, NC.

Reason for recall

"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"

Distribution

"Nationwide in the USA"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0152-2018	Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 76045-001-20	203136 syringes	Class I	Terminated	10 Jan 2018

Context

13%of 2017 drug events are Class I343 events that year

1product record in this eventfirm median: 1

67events on this register for the firm

Other enforcement events for Fresenius Kabi USA, LLC

Initiated	Product (first record)	Type	Class	Records
10 Aug 2026	Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, L	Drug	Class I	1
4 Aug 2026	Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenou	Drug	Class I	1
16 Jul 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 Vi	Drug	Class II	5
14 May 2026	Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696	Drug	Class III	1
6 May 2026	Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004	Device	Class I	1
6 May 2026	LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.	Device	Class I	1
11 Mar 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,	Drug	Class II	14
4 Feb 2026	The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.	Device	Class II	1
21 Nov 2025	Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.	Device	Class II	1
14 Nov 2025	Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients	Device	Class I	1

All 67 events for Fresenius Kabi USA, LLC

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "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"

What does Class I mean?

FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide in the USA"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 5 Oct 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.