Quick answers
- What is Hyaluronidase (hyaluronidase (human recombinant)) used for?
- The FDA-approved label (HYLENEX Recombinant, Antares Pharma, Inc., November 11, 2024) says: “1. Indications and Usage HYLENEX recombinant is an endoglycosidase indicated as an adjuvant in subcutaneous fluid administration for achieving hydration to increase the dispersion and absorption of other injected drugs in subcutaneous urography for improving resorption of radiopaque agents 1.1. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Hyaluronidase (hyaluronidase (human recombinant)) have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Hyaluronidase (hyaluronidase (human recombinant))?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Hyaluronidase (hyaluronidase (human recombinant)) been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started September 11, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Hyaluronidase (hyaluronidase (human recombinant))?
- 2 companies list prescription products of Hyaluronidase (hyaluronidase (human recombinant)) in the FDA NDC Directory, including Antares Pharma, Inc. and HF Acquisition Co LLC, DBA HealthFirst.
What Hyaluronidase (hyaluronidase (human recombinant)) is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
1. Indications and Usage HYLENEX recombinant is an endoglycosidase indicated as an adjuvant in subcutaneous fluid administration for achieving hydration to increase the dispersion and absorption of other injected drugs in subcutaneous urography for improving resorption of radiopaque agents 1.1. …
— FDA label: HYLENEX Recombinant, Antares Pharma, Inc., effective November 11, 2024. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Hylenex Recombinant |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| hyaluronidase (human recombinant) 150 USP units/mL injection, solution | Brand: HYLENEX Recombinant | $53.58 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Antares Pharma, Inc.1 product
- HF Acquisition Co LLC, DBA HealthFirst1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA021859 HYLENEX RECOMBINANT | Halozyme Therap | December 2, 2005 | 14, latest January 12, 2024 2024: Labeling · 2016: Manufacturing (CMC) · 2016: Manufacturing (CMC) |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
September 11, 2024 · Class II · Terminated · D-0116-2025
cGMP Deviations: Temperature excursion
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 — Mckesson Medical-Surgical Inc. Corporate Office
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 630936, 630939 |
|---|---|
| SPL set ID of the quoted label | 3023cc56-ed4b-4e87-b3a1-81b20943f658 |
| FDA labels (SPL) | 2 |
| FDA applications | BLA021859 |
| Active ingredients (FDA) | HYALURONIDASE (HUMAN RECOMBINANT) |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — HYLENEX Recombinant, Antares Pharma, Inc., effective November 11, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →