Quick answers
- What is Goserelin used for?
- The FDA-approved label (Zoladex, TerSera Therapeutics LLC, March 24, 2026) says: “ZOLADEX is a Gonadotropin Releasing Hormone (GnRH) agonist indicated for: Use in combination with flutamide for the management of locally confined carcinoma of the prostate Palliative treatment of advanced carcinoma of the prostate The management of endometriosis Use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding Use in the palliative treatment of advanced breast …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Goserelin 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 Goserelin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Goserelin been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started August 31, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Goserelin?
- 1 company lists prescription products of Goserelin in the FDA NDC Directory, including TerSera Therapeutics LLC.
What Goserelin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ZOLADEX is a Gonadotropin Releasing Hormone (GnRH) agonist indicated for: Use in combination with flutamide for the management of locally confined carcinoma of the prostate Palliative treatment of advanced carcinoma of the prostate The management of endometriosis Use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding Use in the palliative treatment of advanced breast …
— FDA label: Zoladex, TerSera Therapeutics LLC, effective March 24, 2026. 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.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
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 | Implant |
|---|---|
| Route | Subcutaneous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Zoladex |
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.
- TerSera Therapeutics LLC2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA019726 ZOLADEX | Tersera | December 29, 1989 | 46, latest May 6, 2026 2026: Labeling · 2025: Labeling · 2023: Labeling |
| NDA020578 ZOLADEX | Tersera | January 11, 1996 | 27, latest May 6, 2026 2026: Labeling · 2025: Labeling · 2021: Labeling |
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.
-
August 31, 2026 · Class II · Ongoing · D-0875-2026
Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.
Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a carton, Rx only, Manufactured for: TerSera therapeutics LLC, Deerfield, IL 60015, BY: AstraZeneca UK Limited, Macclesfield, England, Product of Sw — TerSera Therapeutics LLC
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) | 105641, 211544, 310592, 314008 |
|---|---|
| SPL set ID of the quoted label | 294b168b-6e5f-4db9-bf70-d599271458b3 |
| FDA labels (SPL) | 2 |
| FDA applications | NDA019726, NDA020578 |
| Active ingredients (FDA) | GOSERELIN ACETATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Zoladex, TerSera Therapeutics LLC, effective March 24, 2026; 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 →