Vitamin K, Warfarin Reversal Agent
Where is Phytonadione made?
25 companies sell it under their own name and 11 repackagers rebottle it. Their labels name 15 factories in India, the United States and Switzerland.
India 10United States 4Switzerland 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Cipla USA., Inc.1 mg per 0.5 mL, 5 mg, 10 mg per 1 mL · NDC 69097-709, 69097-003, 69097-708 +1 | DSM Nutritional Products AG Zweigniederlassung Werk SisselnMakes the active ingredient | Sisseln AG, Switzerland | Problems found, fixed voluntarilyMay 2025 |
| Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 | |
| Immacule Lifesciences Private LimitedMakes it | Solan, India | Serious problems, FDA actionSep 2025 | |
| ScieGen Pharmaceuticals, INC.Makes it, tests it, packages it and labels it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 | |
| Dr. Reddy's Laboratories Inc.1 mg per 0.5 mL, 10 mg per 1 mL · NDC 43598-032, 43598-405 | Dr.reddy's Laboratories LimitedMakes it and tests it | Visakhapatnam, India | Problems found, fixed voluntarilyMay 2024 |
| Gland Pharma LimitedMakes it and tests it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 | |
| Agnitio Inc.5 mg · NDC 72134-008 | Agnitio Inc.Makes it | Appleton, WI, United States | No problems foundNov 2025 |
| Alembic Pharmaceuticals Inc.1 mg per 0.5 mL · NDC 62332-826 | Alembic Pharmaceuticals LimitedMakes it | Vadodara, India | Problems found, fixed voluntarilyFeb 2026 |
| Alembic Pharmaceuticals Limited1 mg per 0.5 mL · NDC 46708-826 | Alembic Pharmaceuticals LimitedMakes it | Vadodara, India | Problems found, fixed voluntarilyFeb 2026 |
| Amneal Pharmaceuticals5 mg · NDC 69238-1051 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | No problems foundJul 2024 |
| Amneal Pharmaceuticals LLC1 mg per 0.5 mL · NDC 70121-1682 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and sterilizes it | Ahmedabad, India | No problems foundJun 2024 |
| Amneal Pharmaceuticals Private Limited10 mg per 1 mL · NDC 80830-1683 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it, labels it and sterilizes it | Ahmedabad, India | No problems foundAug 2024 |
| Baxter Healthcare Corporation1 mg per 0.5 mL · NDC 43066-132 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| Cadila Healthcare Limited5 mg · NDC 70771-1318 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Caplin Steriles Limited10 mg per 1 mL · NDC 65145-151 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| Caraco Pharmaceutical Laboratories, Ltd.1 mg per 0.5 mL · NDC 70095-154 | Gland Pharma LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Exelan Pharmaceuticals, Inc.5 mg · NDC 76282-740 | ScieGen Pharmaceuticals, INC.Makes it, tests it, packages it and labels it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 |
| Fresenius Kabi USA, LLC10 mg per 1 mL · NDC 65219-635 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| Gland Pharma Limited10 mg per 1 mL · NDC 68083-606 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 |
| Glenmark Pharmaceuticals Inc., USA10 mg per 1 mL · NDC 68462-758 | Gland Pharma LimitedMakes it, tests it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 |
| Hospira, Inc.2 mg per 1 mL, 10 mg per 1 mL · NDC 0409-9158, 0409-9157 | Hospira, Inc.Makes it, tests it, packages it and labels it | Rocky Mount, NC, United States | No problems foundFeb 2025 |
| International Medication Systems, Ltd.1 mg per 0.5 mL · NDC 76329-1240 | International Medication Systems, Ltd.Makes it, makes the active ingredient and tests it | South El Monte, CA, United States | Serious problems, FDA actionDec 2025 |
| Northstar Rx LLC.5 mg · NDC 16714-973 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Orbicular Pharmaceutical Technologies Private Limited1 mg per 0.5 mL · NDC 81607-020 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| ScieGen Pharmaceuticals, Inc.5 mg · NDC 50228-333 | ScieGen Pharmaceuticals, INC.Makes it and tests it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 |
| Zydus Pharmaceuticals (USA) Inc.5 mg · NDC 70710-1014 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Padagis US LLC5 mg · NDC 0574-1850 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals1 mg per 0.5 mL · NDC 25021-505 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Xiromed, LLC.10 mg per 1 mL · NDC 70700-331 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Phytonadione in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- A-S Medication Solutions:
50090-4521,50090-4523,50090-1753 - American Health Packaging:
60687-381 - Carilion Materials Management:
68151-0158 - Coupler LLC:
67046-1581 - General Injectables & Vaccines, Inc.:
52584-043,52584-240 - HF Acquisition Co. LLC. DBA HealthFirst:
51662-1536,51662-1698,51662-1537 - Henry Schein, Inc.:
0404-9935,0404-9969 - Major Pharmaceuticals:
0904-6882 - Physicians Total Care, Inc.:
54868-5438 - Rebel Distributors Corp..:
21695-168 - Safecor Health, LLC:
48433-160
Recalls
- Oct 31, 2025 · Class II · Cipla Limited
Failed Stability Specifications: Observed OOS results: eg results for colour index - Sep 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. - Mar 16, 2020 · Class I · Dr. Reddy's Laboratories, Inc.
Defective Container: Recall is due to breaking and shattering of ampules upon opening
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.