Food, drugs, devices › Fresenius Kabi USA, LLC

Drug recall: Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Si

FDA enforcement event 85504 · Class I · initiated 20 Apr 2020 · status Terminated · terminated 16 Oct 2023

DrugVoluntary: Firm initiated2 product recordsLake Zurich, IL

FDA enforcement event 85504 is a drug recall by Fresenius Kabi USA, LLC of Lake Zurich, IL, initiated 20 Apr 2020 and classified Class I, with 2 product records.

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. 15% of the 342 drug enforcement events initiated in 2020 carry the same class.

Status: Terminated, terminated 16 Oct 2023. 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, Lake Zurich, IL.

Reason for recall

"Presence of Particulate Matter - found in reserve sample vials at the firm."

Distribution

"USA Nationwide and Puerto Rico"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-1296-2020	Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.	5,314,400 vials	Class I	Terminated	17 Jun 2020
D-1297-2020	Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC 63323-162-03), 25 x 2 mL Single Dose Vials per tray (NDC 63323-162-02); For IM use only, Not for IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.	3,497,575 vials	Class II	Terminated	17 Jun 2020

Context

15%of 2020 drug events are Class I342 events that year

2product records 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: "Presence of Particulate Matter - found in reserve sample vials at the firm."

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: "USA Nationwide and Puerto Rico"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 16 Oct 2023. "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.