Folate Analog
Where is Leucovorin made?
17 companies sell it under their own name and 4 repackagers rebottle it. Their labels name 11 factories in the United States, China, Portugal, Spain, Austria, India and 1 other.
United States 4China 2Portugal 1Spain 1Austria 1India 1Switzerland 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| BluePoint Laboratories.100 mg per 10 mL, 200 mg per 20 mL, 350 mg per 17.5 mL · NDC 68001-416, 68001-648, 68001-417 +3 | Hikma Farmaceutica (portugal), S.aMakes it, tests it, packages it and labels it | Terrugem Sintra, Portugal | Problems found, fixed voluntarilyApr 2023 |
| Kindos Pharmaceuticals Co., Ltd.Makes it | Chengdu, China | Problems found, fixed voluntarilyJul 2024 | |
| Fresenius Kabi, LLC10 mg per 1 mL, 200 mg per 20 mL, 500 mg per 50 mL · NDC 63323-631, 63323-710, 63323-711 | Fresenius Kabi AustriaMakes it and tests it | Austria 8055, Austria | Problems found, fixed voluntarilyMar 2024 |
| Fresenius Kabi USA, LLCMakes it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 | |
| Hikma Pharmaceuticals USA Inc.5 mg, 10 mg, 15 mg, 25 mg · NDC 0054-4497, 0054-4498, 0054-4499 +2 | Cerbios-Pharma SAMakes the active ingredient | Barbengo/Lugano, Switzerland | Problems found, fixed voluntarilyMar 2024 |
| West-Ward Columbus Inc.Makes it | Columbus, OH, United States | No problems foundApr 2026 | |
| Epic Pharma, LLC5 mg, 10 mg, 15 mg, 25 mg · NDC 42806-133, 42806-134, 42806-359 +1 | Epic Pharma, LLCMakes it | Laurelton, NY, United States | Problems found, fixed voluntarilyJun 2026 |
| Farmasierra Manufacturing SL5 mg · NDC 73591-5886 | Farmasierra Manufacturing SLMakes it, tests it, packages it and labels it | San Sebastian de los Reyes, Spain | Problems found, fixed voluntarilyJan 2024 |
| Gland Pharma Limited350 mg per 17.5 mL, 500 mg per 50 mL · NDC 68083-587, 68083-668 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Glenmark Pharmaceuticals Inc., USA350 mg per 17.5 mL · NDC 68462-767 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Leading Pharma, LLC5 mg, 10 mg, 15 mg, 25 mg · NDC 69315-185, 69315-186, 69315-187 +1 | Leading Pharma, LLCMakes it | Fairfield, NJ, United States | Problems found, fixed voluntarilyOct 2024 |
| Meitheal Pharmaceuticals Inc.50 mg per 5 mL, 100 mg per 10 mL, 200 mg per 20 mL, 350 mg per 17.5 mL, 500 mg per 50 mL · NDC 71288-161, 71288-162, 71288-163 +2 | Kindos Pharmaceuticals Co., Ltd.Makes it | Chengdu, China | Problems found, fixed voluntarilyJul 2024 |
| Slate Run Pharmaceuticals, LLC.50 mg, 100 mg, 200 mg, 350 mg, 500 mg · NDC 70436-117, 70436-118, 70436-119 +2 | Hainan Poly Pharm. Co., Ltd.Makes it | Haikou, China | Problems found, fixed voluntarilyJun 2023 |
| Avyxa Pharma, LLC Vykoura50 mg per 5 mL, 350 mg per 35 mL, 500 mg per 50 mL · NDC 83831-148, 83831-147, 83831-149 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc.50 mg per 5 mL, 100 mg per 10 mL, 200 mg per 20 mL, 350 mg per 17.5 mL · NDC 0143-9554, 0143-9553, 0143-9368 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Ingenus Pharmaceuticals, LLC5 mg, 10 mg, 15 mg, 25 mg · NDC 50742-182, 50742-183, 50742-184 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Institutional LLC100 mg per 10 mL, 200 mg per 20 mL, 350 mg per 17.5 mL · NDC 67457-528, 67457-529, 67457-530 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Pfizer Laboratories Div Pfizer Inc5 mg · NDC 0069-5886 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals50 mg per 5 mL, 100 mg per 10 mL, 200 mg per 20 mL, 350 mg per 17.5 mL, 500 mg per 50 mL · NDC 25021-814, 25021-815, 25021-816 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.5 mg, 25 mg · NDC 0555-0485, 0555-0484 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Leucovorin 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.
- American Health Packaging:
60687-227 - Major Pharmaceuticals:
0904-7584 - Physicians Total Care, Inc.:
54868-5915,54868-3310 - Proficient Rx LP:
71205-908
Recalls
- Jul 22, 2020 · Class III · West-Ward Columbus Inc
Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.