Drug recall: Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for…

Class II FDA enforcement event 95830. Recall start date: 11 Sep 2024. Status in the FDA record: Terminated. Termination date: 20 Aug 2025.

Reason for recall, in the words of FDA

cGMP Deviations: Temperature excursion

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

Mckesson Medical-Surgical Inc. Corporate Office started this drug recall on 11 Sep 2024. The firm address in the FDA record is in Richmond, VA. FDA put the recall in Class II. FDA event 95830 has 1 product record. The first FDA enforcement report date is 18 Dec 2024. The record gives the status Terminated, with the termination date 20 Aug 2025.

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.

Virgina

Recalling firm

Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA.

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 95830: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0116-2025	Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halozyme, Inc., 12390 El Camino Real San Diego California 92130, Distributed by Antares Pharma, Inc., Ewing, NJ NDC 18657-117-04	5 cartons/20 units each carton	Class II	Terminated	18 Dec 2024

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 2024: 319
Share of these events in Class II: 71%
Product records in this event: 1Median of the firm: 3
Events of the firm on the register: 15

Other events of the firm

Other FDA enforcement events of Mckesson Medical-Surgical Inc. Corporate Office
Initiated	Product (first record)	Type	Class	Records
30 Jul 2025	Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020	Device	Class II	1
25 Apr 2025	Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Single-Dose Vial, Rx only, Mfd. in India for:	Drug	Class II	2
24 Apr 2025	ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL	Device	Class II	32
21 Apr 2025	PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks,	Drug	Class II	3
17 Sep 2024	Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a con	Device	Class II	1
11 Sep 2024	Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208	Drug	Class II	1
23 Apr 2024	Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS Catalog Numbe	Device	Class II	1
7 Feb 2024	Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma L	Drug	Class II	3
9 Jan 2024	Sekisui Diagnostics Control Kit OSOM BVBLUE Bacterial Vaginosis	Device	Class II	5
29 Jun 2022	Triple Antibiotic Ointment, Bacitracin zinc, Neomycin sulfate, Polymixin B sulfate, First Aid Antibiotic, Triple Antibio	Drug	Class II	17

Mckesson Medical-Surgical Inc. Corporate Office: all 15 events

Official channels

FDA enforcement report D-0116-2025The 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 95830. https://recallregister.com/fda/ii/95830/. 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: Virgina
What quantity of product is in FDA event 95830?: The FDA record gives this quantity: 5 cartons/20 units each carton
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2024 have the same class?: 71% of the 319 drug events that started in 2024 are in Class II.