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Hyaluronidase

Hylenex recombinant (hyaluronidase)

Halozyme (manufacturer); distributed by Antares Pharma, Inc.

Licensed biologic (FDA)Checked Sep 14, 2026 · Read on the pages cited

What it is

Maker
Halozyme (manufacturer); distributed by Antares Pharma, Inc.
Category
Hyaluronidase
Also called
Hylenex, hyaluronidase human injection, hyaluronidase

FDA status

Pathway
Licensed biologic (FDA)
First approved or cleared
2005

Research notes

Drugs@FDA lists 021859 as a BLA (original approval 2005-12-02; 'This Former NDA Was Deemed To Be a BLA on March 23, 2020'). Dissolving hyaluronic-acid fillers is not among the labeled indications on the opened label; clinics that keep hyaluronidase on hand for filler complications are using it outside those listed indications. No label warning was captured.

What it’s authorized for

As recorded from the FDA record and labeling cited below.

  • Added to subcutaneous (under-the-skin) fluid administration to help achieve hydration
  • To increase the spread and absorption of other injected drugs
  • In subcutaneous urography, to improve absorption of contrast (radiopaque) agents

How it’s sold

150 USP units/mL solution in a single-dose vial

What the label warns about

No label warning is recorded here. That isn’t the same as the label having none — the research notes and sources say what was opened.

Checking it’s the real thing

No FDA authenticity notice is recorded for this product.

Ask in the room

“What’s the brand name printed on the box, vial or device panel — and may I see it?”

Recalls and enforcement

FDA recall and enforcement records filed under BLA 021859, read live from openFDA. A recall usually covers particular models or lots, not every unit ever made.

Searching FDA recall and enforcement records by this product’s FDA number…

Look up BLA 021859 and a number from the box

Check it yourself

Device proof ladder: The room sells a laser, RF, microneedling, body-contouring, light, or other hardware result. Work down in order — each step needs the one before it.

  1. Read the panelGet the exact manufacturer and model from the device itself.
  2. Find the authorizationSearch 510(k) and De Novo by model/manufacturer, not treatment nickname.510(k) Premarket Notification database (opens in a new tab) · U.S. Food & Drug Administration
  3. Match identityUse AccessGUDID when a UDI or device identifier is available.AccessGUDID (opens in a new tab) · FDA / National Library of Medicine
  4. Read maker instructionsCompare the proposed use with current manufacturer labeling/IFU for that exact model.
  5. Check post-market recordSearch recalls/corrections after the model is known.Medical Device Recalls (opens in a new tab) · U.S. Food & Drug Administration
  6. Verify the operatorThen check the person's applicable state credential and device-specific training.

Worth knowing

What an FDA record can and can’t tell you

FDA records show what was authorized, for what, and when.

They can’t show that the product in the room is authentic, in date, stored properly, or being used for its authorized purpose. Those are questions for the room.

Sources

  1. Drugs@FDA: 021859 (Hylenex Recombinant) (opens in a new tab)FDA database
  2. DailyMed: HYLENEX recombinant prescribing information (revised 11/2024) (opens in a new tab)Label

Checked Sep 14, 2026 · Read on the pages cited.

Treatments that use it

No treatment guide lists this product yet.

Product identity

Told a name? Shown a box?

Type what was said or printed, see whether it matches a registry entry, and note what you saw in your booking file.

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