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Prescription medicine

Trastuzumab and hyaluronidase-oysk

Brand names: Herceptin Hylecta

Active ingredients: hyaluronidase (human recombinant) · trastuzumab

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Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

None listedFDA shortage list
0Recalls (FDA reports)
1Companies
2019First FDA approval on file

Quick answers

Is there a shortage of Trastuzumab and hyaluronidase-oysk?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Trastuzumab and hyaluronidase-oysk been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Trastuzumab and hyaluronidase-oysk?
1 company lists prescription products of Trastuzumab and hyaluronidase-oysk in the FDA NDC Directory, including Genentech, Inc..

What Trastuzumab and hyaluronidase-oysk is used for

We did not find an “Indications and Usage” section in the FDA labels for this medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Forms and how it is given

Dosage formsInjection, solution
RouteSubcutaneous
Prescription products1 in the FDA NDC Directory
Brand namesHerceptin Hylecta

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.

FDA approval history

  • BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
BLA761106
HERCEPTIN HYLECTA		 Genentech IncFebruary 28, 2019 2, latest May 18, 2026
2026: Labeling · 2024: Efficacy

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

FDA labels (SPL)0
FDA applicationsBLA761106
Active ingredients (FDA)HYALURONIDASE (HUMAN RECOMBINANT) / TRASTUZUMAB

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  4. 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 →

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