Nucleoside Metabolic Inhibitor
Where is Fluorouracil made?
20 companies sell it under their own name and 5 repackagers rebottle it. Their labels name 14 factories in India, the United States, China, Canada and Israel.
India 6United States 4China 2Canada 1Israel 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Accord Healthcare Inc.50 mg per 1 g, 50 mg per 1 mL · NDC 16729-542, 16729-276 | 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 | |
| Bausch Health US, LLC Efudex0.5 g per 10 mL, 1.25 g per 10 mL, 2 g per 40 g · NDC 0187-3202, 0187-3203, 0187-3204 | Bausch Health Companies Inc.Makes it | Laval, Canada | No problems foundJan 2024 |
| Kavis Pharma LLCMakes it | Sugar Land, TX, United States | Problems found, fixed voluntarilyApr 2025 | |
| BluePoint Laboratories.50 mg per 1 mL · NDC 68001-628, 68001-627, 68001-525 +1 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | Problems found, fixed voluntarilyMar 2024 |
| Gland Pharma LimitedMakes it, tests it and packages it | Visakhapatnam, India | No problems foundJul 2023 | |
| Alembic Pharmaceuticals Inc.50 mg per 1 mL · NDC 62332-751, 62332-779 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | Problems found, fixed voluntarilyMar 2024 |
| Alembic Pharmaceuticals Limited50 mg per 1 mL · NDC 46708-751, 46708-779 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | Problems found, fixed voluntarilyMar 2024 |
| AuroMedics Pharma LLC50 mg per 1 mL · NDC 55150-496, 55150-497, 55150-498 +1 | EUGIA Pharma Specialities LimitedMakes it, tests it and packages it | Medchal-Malkajgiri, India | No problems foundJul 2023 |
| Avyxa Pharma, LLC Favlyxa25 mg per 1 mL · NDC 83831-143, 83831-164 | Sichuan Huiyu Pharmaceutical Co., Ltd.Makes it | Neijiang, China | Not inspected on record |
| Caraco Pharmaceutical Laboratories, Ltd.20 mg per 1 mL, 50 mg per 1 g, 50 mg per 1 mL · NDC 51672-4062, 51672-4118, 51672-4063 | Taro Pharmaceutical Industries Ltd.Makes it | Haifa Bay, Israel | No problems foundDec 2022 |
| Dr. Reddy's Laboratories Inc.5 mg per 1 g, 50 mg per 1 g · NDC 75907-169, 75907-095 | Kavis Pharma LLCMakes it, tests it, packages it and labels it | Sugar Land, TX, United States | Problems found, fixed voluntarilyApr 2025 |
| Encube Ethicals, Inc.2 g per 40 g, 50 mg per 1 mL · NDC 21922-049, 21922-041 | Encube Ethicals LimitedMakes it, tests it, packages it and labels it | Ponda, India | Problems found, fixed voluntarilyJun 2024 |
| Fresenius Kabi, LLC50 mg per 1 mL · NDC 63323-117 | Fresenius Kabi USA, LLCMakes it and tests it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 |
| Gland Pharma Limited50 mg per 1 mL · NDC 68083-269, 68083-270, 68083-292 +1 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Visakhapatnam, India | No problems foundJul 2023 |
| Hill Dermaceuticals, Inc. Tolak0.04 g per 1 g · NDC 28105-421 | Hill Dermaceuticals, Inc.Makes it | Sanford, FL, United States | Problems found, fixed voluntarilyOct 2025 |
| Mayne Pharma Inc.50 mg per 1 g · NDC 51862-362 | Rockledge Pharmaceutical Manufacturing, LLCMakes it | Rockledge, FL, United States | Problems found, fixed voluntarilyApr 2025 |
| Meitheal Pharmaceuticals Inc.50 mg per 1 mL · NDC 71288-170, 71288-154 | Kindos Pharmaceuticals Co., Ltd.Makes it | Chengdu, China | Problems found, fixed voluntarilyJul 2024 |
| Northstar Rx LLC.50 mg per 1 g · NDC 16714-178 | Taro Pharmaceutical Industries Ltd.Makes it | Haifa Bay, Israel | No problems foundDec 2022 |
| Xiromed, LLC.50 mg per 1 mL · NDC 70700-187, 70700-186, 70700-188 +1 | Gland Pharma LimitedMakes it, tests it and packages it | Visakhapatnam, India | No problems foundJul 2023 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.50 mg per 1 mL · NDC 23155-974, 23155-975, 23155-972 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.5 mg per 1 g · NDC 0378-4791 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals50 mg per 1 mL · NDC 25021-215 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Fluorouracil 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:
50090-4264 - NuCare Pharmaceuticals.Inc.:
68071-2961,68071-3489 - Physicians Total Care, Inc.:
54868-6293 - ProPharma Distribution:
84549-117 - Rebel Distributors Corp..:
21695-829
Recalls
- Jun 28, 2019 · Class I · Fresenius Kabi USA, LLC
Presence of Particulate Matter; glass particulates - Nov 21, 2012 · Class II · Taro Pharmaceuticals U.S.A., Inc.
Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.