Folate Analog Metabolic Inhibitor
Where is Methotrexate made?
22 companies sell it under their own name and 12 repackagers rebottle it. Their labels name 14 factories in India, the United States, Finland, Canada, Australia and the United Kingdom.
India 6United States 3Finland 2Canada 1Australia 1United Kingdom 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Accord Healthcare Inc.2.5 mg, 25 mg per 1 mL · NDC 16729-486, 16729-277 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | No problems foundJul 2024 |
| Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | Serious problems, FDA actionDec 2022 | |
| AuroMedics Pharma LLC50 mg per 2 mL, 100 mg per 4 mL, 200 mg per 8 mL, 250 mg per 10 mL · NDC 55150-511, 55150-512, 55150-513 +1 | EUGIA Pharma Specialities LimitedMakes it, tests it and packages it | Medchal-Malkajgiri, India | No problems foundJul 2023 |
| Mylan Laboratories LimitedMakes it, tests it, packages it, labels it and sterilizes it | Bangalore, India | Problems found, fixed voluntarilyMay 2022 | |
| Caraco Pharmaceutical Laboratories, Ltd.2.5 mg · NDC 47335-235 | Orion Corporation, Orion PharmaMakes it, tests it, packages it and labels it | Espoo, Finland | Problems found, fixed voluntarilyNov 2024 |
| Orion Corporation, Orion PharmaMakes it | Turku, Finland | Problems found, fixed voluntarilyApr 2024 | |
| Alembic Pharmaceuticals Inc.2.5 mg, 25 mg per 1 mL · NDC 62332-730, 62332-711, 62332-712 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | Problems found, fixed voluntarilyMar 2024 |
| Alembic Pharmaceuticals Limited2.5 mg, 25 mg per 1 mL · NDC 46708-730, 46708-711, 46708-712 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | Problems found, fixed voluntarilyMar 2024 |
| Antares Pharma, Inc. Otrexup7.5 mg per 0.4 mL, 10 mg per 0.4 mL, 12.5 mg per 0.4 mL, 15 mg per 0.4 mL, 17.5 mg per 0.4 mL, 20 mg per 0.4 mL · NDC 54436-010, 54436-012, 54436-015 +5 | Pharmascience Inc.Makes it | Candiac, Canada | Problems found, fixed voluntarilyFeb 2024 |
| Aurobindo Pharma Limited2.5 mg · NDC 59651-182 | EUGIA Pharma Specialities LimitedMakes it and tests it | Medchal-Malkajgiri, India | No problems foundJul 2023 |
| Cadila Healthcare Limited2.5 mg · NDC 70771-1058 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Elite Laboratories, Inc.2.5 mg · NDC 64850-330 | Elite Laboratories, Inc.Makes it and labels it | Northvale, NJ, United States | Problems found, fixed voluntarilyAug 2025 |
| Fresenius Kabi, LLC1 g, 25 mg per 1 mL · NDC 63323-122, 63323-123 | Fresenius Kabi USA, LLCMakes it and tests it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 |
| Hikma Pharmaceuticals USA Inc.2.5 mg · NDC 0054-4550, 0054-8550 | West-Ward Columbus Inc.Makes it | Columbus, OH, United States | No problems foundApr 2026 |
| Hospira, Inc.25 mg per 1 mL · NDC 61703-350, 61703-408, 61703-124 +1 | Hospira Australia Pty LtdMakes it, tests it, packages it and labels it | Mulgrave, Australia | Problems found, fixed voluntarilySep 2022 |
| Shorla Oncology Inc. Jylamvo2 mg per 1 mL · NDC 81927-204 | SGS United Kingdom LimitedMakes it and tests it | Deeside, United Kingdom | Problems found, fixed voluntarilyJul 2023 |
| Zydus Pharmaceuticals (USA) Inc.2.5 mg · NDC 68382-775 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) Xatmep2.5 mg per 1 mL · NDC 52652-2001 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.2.5 mg · NDC 62135-772 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc.1 g, 25 mg per 1 mL · NDC 0143-9367, 0143-9830, 0143-9519 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Medexus Pharma, Inc. Rasuvo7.5 mg per 0.15 mL, 10 mg per 0.2 mL, 12.5 mg per 0.25 mL, 15 mg per 0.3 mL, 17.5 mg per 0.35 mL, 20 mg per 0.4 mL · NDC 59137-510, 59137-515, 59137-520 +6 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.2.5 mg · NDC 0378-0014 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Parenteral Medicines, Inc.25 mg per 1 mL · NDC 0703-3671, 0703-3675, 0703-3678 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.2.5 mg · NDC 0555-0572 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Women's Health LLC5 mg, 7.5 mg, 10 mg, 15 mg · NDC 51285-368, 51285-369, 51285-366 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Methotrexate 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:
50090-2345,50090-5457 - American Health Packaging:
60687-975 - AvKARE, Inc.:
42291-594 - AvPAK:
50268-554 - Bryant Ranch Prepack:
72162-2174,71335-0782,71335-1772,72162-2647+2 - Coupler LLC:
67046-1524 - Golden State Medical Supply, Inc.:
51407-121 - Major Pharmaceuticals:
0904-7141 - Mylan Institutional Inc.:
51079-670 - NuCare Pharmaceuticals.Inc.:
68071-3765,68071-3991 - Proficient Rx LP:
82804-136 - Safecor Health, LLC:
48433-065
Recalls
- Sep 22, 2023 · Class III · West-Ward Columbus Inc
Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring. - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - Jun 27, 2012 · Class II · Hospira Inc.
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product …
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.