Prescription medicine
Phytonadione Brand names: Vitamin; first approved as Mephyton
Phytonadione (Vitamin) is a prescription medicine with an FDA approval on record since 1955. FDA's NDC Directory lists it from 32 generic labelers, and pharmacies paid $8.83 per phytonadione 5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the phytonadione FDA label on DailyMed (effective August 9, 2026, Hospira, Inc.); the NDA 10104 record on Drugs@FDA; every phytonadione label on DailyMed.
Highlights of the record
FDA label of August 9, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
HYPERSENSITIVITY REACTIONS WITH INTRAVENOUS AND INTRAMUSCULAR USE.
Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after intravenous and intramuscular injection of Vitamin K 1 Injection. Reactions have occurred despite dilution to avoid rapid intravenous infusion and upon first dose. Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified [see Warnings and Precautions (5.1) ]. WARNING: HYPERSENSITIVITY REACTIONS WITH INTRAVENOUS AND INTRAMUSCULAR USE See full prescribing information for complete boxed warning. Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after INTRAVENOUS and INTRAMUSCULAR injection of Vitamin K 1 Injection. Reactions have occurred despite dilution to avoid rapid infusion and upon first and subsequent doses. Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified.
Used for
From the label: indications and usageVitamin 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.
Forms and strengths
- 5 mg
- 1 mg/.5ml
- 2 mg/ml
- 10 mg/ml
Injection (emulsion); tablet.
On the market
- Earliest approval on file
- September 30, 1955 Mephyton, Bausch; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 24 first March 1, 1976; 21 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 32 of which 32 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $8.83 per tablet Phytonadione 5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 6 since 2013 1 Class I among all firms' recalls; latest October 31, 2025; 3 more by firms not listed as its makers
- FAERS reports
- 8,435 through July 30, 2026
What is phytonadione used for?
From the label: indications and usageVitamin 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. ( 1.1 )
Hypoprothrombinemia due to antibacterial therapy. ( 1.1 )
Hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis. […]
FDA pharmacologic class: Vitamin K and Warfarin Reversal Agent.
Source: FDA drug label (Vitamin K1), Hospira, Inc., effective August 9, 2026 (SPL set e8808230-2c44-44c6-8cab-8f29b6b34051), via openFDA; the full label on DailyMed
Is there a generic for phytonadione (Vitamin)?
The FDA approved the first generic phytonadione on March 1, 1976. 24 generic applications are approved; 21 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 phytonadione from 32 labelers 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.
- 1955 earliest approval on file
- 1976 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for phytonadione (Vitamin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $8.83 per Phytonadione 5 mg tablet, down 7% from $9.45 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Phytonadione 5 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Phytonadione 5 mg tablet | Generic | $8.83 per tablet | $264.77 | -7% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has phytonadione been recalled?
The FDA's Enforcement Report lists 9 recalls naming phytonadione since 2013: 1 Class I (the most serious), 4 Class II, 4 Class III; 1 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of phytonadione 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 |
|---|---|---|---|
| October 31, 2025 | Class II | Cipla Limited | Failed Stability Specifications: Observed OOS results: eg results for colour index |
| September 14, 2022 | Class III | Dr. Reddy's Laboratories, Inc. | Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content. |
| June 9, 2021 | Class III | AVKARE Inc. | Failed Impurities Specification: Out of specification when measuring the impurity degradant D level. |
| June 8, 2021 | Class III | Bausch Health Companies, Inc. | Failed Impurities/Degradation Specifications |
| January 7, 2021 | Class III | Bausch Health Companies, Inc. | Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D. |
| March 16, 2020 | Class I | Dr. Reddy's Laboratories, Inc. | Defective Container: Recall is due to breaking and shattering of ampules upon opening |
| November 10, 2015 | Class II | Walgreens Infusion Services not a listed maker | Lack of Assurance of Sterility |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup; PHYTONADIONE Tablet, 5 mg may be potentially mislabeled as medroxyPROGESTERone ACETATE, Tablet, 10 mg, NDC 59762374202, Pedigree … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the phytonadione label say about other medicines?
The phytonadione label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Heparin | drug interactions | Should this occur, higher doses of anticoagulant therapy may be needed when resuming anticoagulant therapy, or a change in therapy to a different class of anticoagulant may be necessary (i.e., heparin sodium). |
Source: FDA drug label (Vitamin K1), Hospira, Inc., effective August 9, 2026 (SPL set e8808230-2c44-44c6-8cab-8f29b6b34051), via openFDA; the full label on DailyMed
What do FAERS reports show for phytonadione?
The FDA Adverse Event Reporting System holds 8,435 reports that list phytonadione among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,581 are coded as a death and 3,908 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?
- Other vitamin ks
- the pharmacologic class, with prices and generics
- Phytonadione side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other