Drug recall: Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use…

Class II FDA enforcement event 68152. Recall start date: 2 May 2014. Status in the FDA record: Terminated. Termination date: 24 May 2016.

Reason for recall, in the words of FDA

Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.

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 2 May 2014. The firm address in the FDA record is in Melrose Park, IL. FDA put the recall in Class II. FDA event 68152 has 2 product records. The first FDA enforcement report date is 16 Jul 2014. The record gives the status Terminated, with the termination date 24 May 2016.

FDA enforcement report The 2 product records

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.

Nationwide and Puerto Rico

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

2 product records in the event.

FDA event 68152: product records
Recall number	Product	Quantity	Class	Status	Report date
D-1428-2014	Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-02	2,070,500 vials	Class II	Terminated	16 Jul 2014
D-1429-2014	Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-10	728,880 vials	Class II	Terminated	16 Jul 2014

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 2014: 313
Share of these events in Class II: 58%
Product records in this event: 2Median 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-1428-2014The 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 68152. https://recallregister.com/fda/ii/68152/. 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: Nationwide and Puerto Rico
What quantity of product is in FDA event 68152?: The event has 2 product records. The first record gives this quantity: 2,070,500 vials
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2014 have the same class?: 58% of the 313 drug events that started in 2014 are in Class II.