Quick answers
- What is Oxytocin used for?
- The FDA-approved label (Oxytocin, Remedyrepack Inc., September 1, 2026) says: “IMPORTANT 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Oxytocin have a boxed warning?
- The label we quote has no boxed warning, but 5 of 9 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Oxytocin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Oxytocin been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started June 24, 2013 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Oxytocin?
- 5 companies list prescription products of Oxytocin in the FDA NDC Directory, including Par Health USA, LLC, Fresenius Kabi USA, LLC and West-Ward Pharmaceuticals Corp.
What Oxytocin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
IMPORTANT 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. …
— FDA label: Oxytocin, Remedyrepack Inc., effective September 1, 2026. Read the full label on DailyMed →
The FDA has 9 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.
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.
5 of 9 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection · Injection, solution |
|---|---|
| Route | Intravenous · Intramuscular |
| Prescription products | 8 in the FDA NDC Directory |
| Brand names | Pitocin |
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.
- Par Health USA, LLC4 products
- Fresenius Kabi USA, LLC3 products
- West-Ward Pharmaceuticals Corp2 products
- Cardinal Health 107, LLC1 product
- Remedyrepack Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA018248 OXYTOCIN | Fresenius Kabi USA | July 9, 1980 | 23, latest September 20, 2022 2022: Labeling · 2014: Manufacturing (CMC) · 2007: Manufacturing (CMC) |
| NDA018261 PITOCIN | Ph Health | November 19, 1980 | 27, latest May 11, 2021 2021: Labeling · 2016: Manufacturing (CMC) · 2014: Labeling |
Generic approvals (1)
- ANDA200219Hikma Farmaceutica · February 13, 2013
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.
-
June 24, 2013 · Class II · Terminated · D-804-2013
Subpotent Drug; 15-month stability test station
Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Pharmaceuticals, LLC Schaumburg, IL, 60173, NDC 63323-012-01. — Fresenius Kabi USA, LLC
-
June 5, 2012 · Class III · Terminated · D-1420-2012
Labeling: Label Mix-up: Pitocin storage conditions should be labeled, "Store between 20¿ to 25¿C (68¿ to 77¿F)". Pitocin lot 225867 and part of Pitocin lot 231423 were labeled, "Store between 20¿ to 25¿C (28¿ to 77¿F)".
Pitocin (Oxytocin Injection, USP) Synthetic 10 units per mL 10 mL, Rx only, Manufactured and Distributed by: JHP Pharmaceuticals, LLC Rochester, MI 48307 NDC 42023-116-02 — JHP Pharmaceuticals, 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) | 207315, 238013, 1791721, 1791723 |
|---|---|
| SPL set ID of the quoted label | b6f20a2c-3609-4b09-b8f7-8d8eaeb5c242 |
| FDA labels (SPL) | 9 |
| FDA applications | NDA018248, NDA018261, 1 ANDA |
| Active ingredients (FDA) | OXYTOCIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Oxytocin, Remedyrepack Inc., effective September 1, 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 →