Drug recall: Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10…

Class II FDA enforcement event 88194. Recall start date: 25 Jun 2021. Status in the FDA record: Terminated. Termination date: 28 Dec 2022.

Reason for recall, in the words of FDA

Low out of specification results for epinephrine assay.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Fresenius Kabi USA LLC started this drug recall on 25 Jun 2021. The firm address in the FDA record is in Melrose Park, IL. FDA put the recall in Class II. FDA event 88194 has 1 product record. The first FDA enforcement report date is 14 Jul 2021. The record gives the status Terminated, with the termination date 28 Dec 2022.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Distributed Nationwide in the USA

Recalling firm

Fresenius Kabi USA LLC, Melrose Park, IL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 88194: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0651-2021	Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL), 30 mL Single Dose Vial, 25 Vials per Tray, Rx only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047. Vial NDC 63323-487-07, Tray NDC 63323-487-37	234,800 vials	Class II	Terminated	14 Jul 2021

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2021: 299
Share of these events in Class II: 60%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 67

Other events of the firm

Other FDA enforcement events of 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

Fresenius Kabi USA LLC: all 67 events

Official channels

FDA enforcement report D-0651-2021The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 88194. https://recallregister.com/fda/ii/88194/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Distributed Nationwide in the USA
What quantity of product is in FDA event 88194?: The FDA record gives this quantity: 234,800 vials
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2021 have the same class?: 60% of the 299 drug events that started in 2021 are in Class II.