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Prescription medicine · generic available

Phytonadione

Brand names: Vitamin K1

Drug class: Vitamin K, Warfarin Reversal Agent

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

YesBoxed warning
None listedFDA shortage list
3Recalls (FDA reports)
32Companies
1976First FDA approval on file

Quick answers

What is Phytonadione used for?
The FDA-approved label (Vitamin K1, Hospira, Inc., August 9, 2026) says: “Vitamin K 1 Injection is a vitamin K replacement indicated for the treatment of the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. • Anticoagulant-induced hypoprothrombinemia deficiency caused by coumarin or indanedione derivatives. • Hypoprothrombinemia due to antibacterial therapy. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Phytonadione have a boxed warning?
Yes. The FDA label for Vitamin K1 has a boxed warning (“WARNING: HYPERSENSITIVITY REACTIONS WITH INTRAVENOUS AND INTRAMUSCULAR USE”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
Is there a shortage of Phytonadione?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Phytonadione been recalled?
FDA enforcement reports list 3 recalls of products of this medicine; the newest started October 31, 2025 (Class II). A recall usually concerns specific lots, not every product.
Who makes Phytonadione?
32 companies list prescription products of Phytonadione in the FDA NDC Directory, including Cipla USA Inc., HF Acquisition Co LLC, DBA HealthFirst and Hospira, Inc..

What Phytonadione is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Vitamin K 1 Injection is a vitamin K replacement indicated for the treatment of the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. • Anticoagulant-induced hypoprothrombinemia deficiency caused by coumarin or indanedione derivatives. • Hypoprothrombinemia due to antibacterial therapy. …

— FDA label: Vitamin K1, Hospira, Inc., effective August 9, 2026. Read the full label on DailyMed →

The FDA has 34 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.

Ulcerative colitis

Related medical specialties

Gastroenterology

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

This label has a boxed warning. Its heading: WARNING: HYPERSENSITIVITY REACTIONS WITH INTRAVENOUS AND INTRAMUSCULAR USE. Read it on the full label →

23 of 34 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsInjection, emulsion · Tablet
RouteIntramuscular · Intravenous · Subcutaneous · Oral · Parenteral
Prescription products39 in the FDA NDC Directory
Brand namesVitamin K1

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Phytonadione, by strength and form
Strength and formGeneric or brandPharmacies pay
phytonadione 5 mg
tablet		 Generic $9.30 per tablet

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

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.

FDA approval history

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (19)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

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.

  1. October 31, 2025 · Class II · Ongoing · D-0197-2026

    Failed Stability Specifications: Observed OOS results: eg results for colour index

    Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule Lifesciences PVT. Ltd. India. Mfd. for: Cipla USA, Inc. Warren, NJ 07059. Vial NDC# 69097 — Cipla Limited

  2. September 14, 2022 · Class III · Completed · D-0007-2023

    Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.

    Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16 — Dr. Reddy's Laboratories, Inc.

  3. March 16, 2020 · Class I · Terminated · D-1094-2020

    Defective Container: Recall is due to breaking and shattering of ampules upon opening

    Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11) packaged in 25 x 1 mL Single-Dose Ampules per carton (NDC 43598-405-16); Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 0 — Dr. Reddy's Laboratories, Inc.

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)198102, 312424, 727625, 1670192
SPL set ID of the quoted labele8808230-2c44-44c6-8cab-8f29b6b34051
FDA labels (SPL)34
FDA applications19 ANDA
Active ingredients (FDA)PHYTONADIONE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Vitamin K1, Hospira, Inc., effective August 9, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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 →

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