Prescription medicine
Oxytocin Brand names: Pitocin; first approved as Syntocinon
Oxytocin (Pitocin) is a prescription medicine with an FDA approval on record since 1980. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
Check it at the source: the oxytocin FDA label on DailyMed (effective January 12, 2026, Fresenius Kabi USA, LLC); the NDA 18245 record on Drugs@FDA; every oxytocin label on DailyMed.
Highlights of the record
FDA label of January 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageIMPORTANT NOTICE: Oxytocin Injection, USP (synthetic) is indicated for the medical rather than the elective induction of labor.
Forms and strengths
Injection; injection (solution).
On the market
- Earliest approval on file
- April 17, 1980 Syntocinon, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first January 24, 2008; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 1 under generic applications, 4 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)
- 43 since 2012 2 Class I among all firms' recalls; latest July 30, 2025; 27 more by firms not listed as its makers
- FAERS reports
- 2,981 through July 30, 2026
What is oxytocin used for?
From the label: indications and usageIMPORTANT NOTICE: Oxytocin Injection, USP (synthetic) is indicated for the medical rather than the elective induction of labor. Available data and information are inadequate to define the benefits to risks considerations in the use of the drug product for elective induction. Elective induction of labor is defined as the initiation of labor for convenience in an individual with a term pregnancy who is free of medical indications. Antepartum Oxytocin injection (synthetic) is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable, in order to achieve early vaginal delivery for fetal or maternal reasons. […]
FDA pharmacologic class: Oxytocic.
Source: FDA drug label (Oxytocin), Fresenius Kabi USA, LLC, effective January 12, 2026 (SPL set c7fd585a-99b7-4309-b003-a6cbef05372c), via openFDA; the full label on DailyMed
Is there a generic for oxytocin (Pitocin)?
The FDA approved the first generic oxytocin on January 24, 2008. 3 generic applications are approved; 2 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 oxytocin from 1 labeler under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1980 earliest approval on file
- 2008 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has oxytocin been recalled?
The FDA's Enforcement Report lists 70 recalls naming oxytocin since 2012: 2 Class I (the most serious), 62 Class II, 6 Class III; 3 still ongoing. 27 of them are by firms that FDA's NDC Directory does not list as a maker of oxytocin 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 |
|---|---|---|---|
| September 16, 2025 | Class I | IntegraDose Compounding Services LLC not a listed maker | Subpotent Drug: Testing revealed there was no oxytocin in the IV bag. |
| July 30, 2025 | Class II | GenoGenix LLC | Lack of Assurance of Sterility |
| August 17, 2023 | Class II | Central Admixture Pharmacy Services, Inc. | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles |
| July 14, 2023 | Class II | Central Admixture Pharmacy Services, Inc. | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. |
| April 28, 2023 | Class II | Central Admixture Pharmacy Services, Inc. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. |
| April 10, 2023 | Class III | SCA Pharmaceuticals | Subpotent Drug: Out of specification results for low potency was obtained. |
| September 20, 2022 | Class III | QuVa Pharma, Inc. not a listed maker | Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL). |
| June 30, 2022 | Class II | Nephron Sterile Compounding Center LLC | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for oxytocin?
The FDA Adverse Event Reporting System holds 2,981 reports that list oxytocin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 150 are coded as a death and 887 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?
- Oxytocin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other