Prescription medicine
Hydroxyprogesterone caproate
Hydroxyprogesterone caproate is a prescription medicine with an FDA approval on record since 1974. On April 6, 2023 the FDA withdrew the approval of Makena and its generics for preventing preterm birth. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
Check it at the source: the hydroxyprogesterone caproate FDA label on DailyMed (effective June 12, 2026, Eugia US LLC); the NDA 17439 record on Drugs@FDA; every hydroxyprogesterone caproate label on DailyMed.
Highlights of the record
FDA label of June 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageHydroxyprogesterone Caproate Injection, USP is indicated in non-pregnant women: for the treatment of advanced adenocarcinoma of the uterine corpus (Stage III or IV);
Forms and strengths
- 1250 mg/5ml
Injection.
On the market
- Earliest approval on file
- December 26, 1974 Hydroxyprogesterone Caproate, Allergan; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first August 24, 2015; 0 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 1 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2012 0 Class I among all firms' recalls; 14 more by firms not listed as its makers
- FAERS reports
- 133 through July 30, 2026
What is hydroxyprogesterone caproate used for?
From the label: indications and usageHydroxyprogesterone Caproate Injection, USP is indicated in non-pregnant women: for the treatment of advanced adenocarcinoma of the uterine corpus (Stage III or IV); in the management of amenorrhea (primary and secondary) and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer; as a test for endogenous estrogen production and for the production of secretory endometrium and desquamation.
FDA pharmacologic class: Progestin.
Source: FDA drug label (Hydroxyprogesterone Caproate), Eugia US LLC, effective June 12, 2026 (SPL set 687bcf42-f437-42c7-8909-a91f621f55df), via openFDA; the full label on DailyMed
Is there a generic for hydroxyprogesterone caproate?
The FDA approved the first generic hydroxyprogesterone caproate on August 24, 2015. 2 generic applications are approved; 0 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 hydroxyprogesterone caproate from 1 labeler under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1974 earliest approval on file
- 2015 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is hydroxyprogesterone caproate still approved to prevent preterm birth?
The FDA withdrew the approval of Makena and of its generic versions of hydroxyprogesterone caproate injection for reducing the risk of preterm birth on April 6, 2023: the confirmatory trial did not show that the medicine reduces the risk of preterm birth or improves outcomes for newborns.
FDA's NDC Directory lists hydroxyprogesterone caproate from 1 labeler under FDA applications, all of them generic, as read October 8, 2026; a listing is the maker's registration, not proof that a product is sold. Status checked October 8, 2026.
Source: FDA announcement of April 6, 2023
Has hydroxyprogesterone caproate been recalled?
The FDA's Enforcement Report lists 14 recalls naming hydroxyprogesterone caproate since 2012: 0 Class I (the most serious), 14 Class II, 0 Class III; 0 still ongoing. 14 of them are by firms that FDA's NDC Directory does not list as a maker of hydroxyprogesterone caproate and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 26, 2020 | Class II | Innovative Intrathecal Solutions, Inc. … not a listed maker | Lack of Assurance of Sterility |
| January 15, 2020 | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical not a listed maker | Lack of Assurance of Sterility |
| June 26, 2019 | Class II | First Pharma Associates LLC dba Riverpoint Pharmacy not a listed maker | Lack of Assurance of Sterility. |
| February 21, 2019 | Class II | Health Solutions Pharmacy Center Inc dba Professional … not a listed maker | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. |
| June 2, 2015 | Class II | The Compounding Pharmacy of America not a listed maker | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility |
| May 18, 2015 | Class II | Advanced Physician Solutions, Inc. not a listed maker | Lack of Assurance of Sterility |
| October 14, 2014 | Class II | Vann Healthcare Services Inc not a listed maker | Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's … |
| October 6, 2014 | Class II | Oregon Compounding Centers, Inc. dba Creative Compounds not a listed maker | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for hydroxyprogesterone caproate?
The FDA Adverse Event Reporting System holds 133 reports that list hydroxyprogesterone caproate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5 are coded as a death and 38 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other progestins
- the pharmacologic class, with prices and generics
- Hydroxyprogesterone caproate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other