Is there a shortage of Relugolix?

No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).

Has Relugolix been recalled?

No recall linked to the products of this medicine appears in the FDA enforcement reports we use.

1 company lists prescription products of Relugolix in the FDA NDC Directory, including Sumitomo Pharma America, Inc..

Relugolix (Orgovyx): uses, warnings, recalls

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.

Quick answers

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

What Relugolix 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 forms	Tablet, film coated
Route	Oral
Prescription products	1 in the FDA NDC Directory
Brand names	Orgovyx

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.

Sumitomo Pharma America, Inc.1 product

FDA approval history

NDA: New Drug Application: how a new (usually brand-name) medicine is approved.

Brand and biologic applications
Application	Sponsor	Approved	Later changes approved
NDA214621 ORGOVYX	Sumitomo Pharma Am	December 18, 2020	3, latest October 8, 2025 2025: Labeling · 2024: Efficacy · 2023: Labeling

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 applications	NDA214621
Active ingredients (FDA)	RELUGOLIX

Sources

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 →

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Relugolix