Prescription medicine
Cetrorelix Brand names: Cetrotide
Cetrorelix (Cetrotide) is a prescription medicine with an FDA approval on record since 2000. FDA's NDC Directory lists it from 5 generic labelers.
- Generic listed
- A presentation discontinued
Check it at the source: the cetrorelix FDA label on DailyMed (effective September 22, 2025, EMD Serono, Inc.); the NDA 21197 record on Drugs@FDA; every cetrorelix label on DailyMed.
Highlights of the record
FDA label of September 22, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageCetrotide ® (cetrorelix acetate for injection) is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation.
Forms and strengths
Kit.
On the market
- Earliest approval on file
- August 11, 2000 Cetrotide, Emd Serono Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first August 12, 2022; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 5 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- 3 since 2020 0 Class I among all firms' recalls; latest February 9, 2026
- FAERS reports
- 617 through July 30, 2026
What is cetrorelix used for?
From the label: indications and usageCetrotide ® (cetrorelix acetate for injection) is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation.
Source: FDA drug label (Cetrotide), EMD Serono, Inc., effective September 22, 2025 (SPL set aca7768e-28a7-4027-b1d8-e66247665f79), via openFDA; the full label on DailyMed
Is there a generic for cetrorelix (Cetrotide)?
The FDA approved the first generic cetrorelix on August 12, 2022. 6 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists cetrorelix from 5 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2000 earliest approval on file
- 2022 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is cetrorelix in shortage?
No cetrorelix presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated November 13, 2025. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Cetrorelix Acetate, Injection, Kit (NDC 0480-5795-08) | Teva Pharmaceuticals USA, Inc. | To Be Discontinued | November 13, 2025 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has cetrorelix been recalled?
The FDA's Enforcement Report lists 3 recalls naming cetrorelix since 2020: 0 Class I (the most serious), 3 Class II, 0 Class III; 2 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 9, 2026 | Class II | Meitheal Pharmaceuticals, Inc | Defective Delivery System: Missing or duplicated needles within the injection kit |
| April 26, 2023 | Class II | Akorn, Inc. | CGMP Deviations: Firm went out of business and could no longer continue stability studies. |
| June 29, 2020 | Class II | EMD Serono, Inc. | Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for cetrorelix?
The FDA Adverse Event Reporting System holds 617 reports that list cetrorelix among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 7 are coded as a death and 217 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Cetrorelix side effects
- the label's list beside FAERS reports
- Cetrorelix shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other