Antimycobacterial
Where is Ethambutol made?
6 companies sell it under their own name and 7 repackagers rebottle it. Their labels name 5 factories in India, the United States and Canada.
India 3United States 1Canada 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Lupin Pharmaceuticals, Inc.100 mg, 400 mg · NDC 68180-280, 68180-281 | Lupin LimitedMakes it and packages it | Salcette, India | Problems found, fixed voluntarilyNov 2025 |
| Lupin LimitedMakes it and packages it | Nagpur, India | Problems found, fixed voluntarilyJul 2023 | |
| Epic Pharma, LLC100 mg, 400 mg · NDC 42806-101, 42806-102 | Epic Pharma, LLCMakes it | Laurelton, NY, United States | Problems found, fixed voluntarilyJun 2026 |
| Kanchan Healthcare Inc Ethambutol Hydrochloride100 mg, 400 mg · NDC 85742-005, 85742-006 | Cadila Pharmaceuticals LimitedMakes it | Ahmedabad, India | No problems foundSep 2025 |
| Marlex Pharmaceuticals, Inc. Ethambutol Hydrochloride100 mg, 400 mg · NDC 10135-796, 10135-797 | Cadila Pharmaceuticals LimitedMakes it | Ahmedabad, India | No problems foundSep 2025 |
| STI Pharma100 mg, 400 mg · NDC 68850-004, 68850-005 | Patheon Inc.Makes it | Whitby, Canada | Problems found, fixed voluntarilyFeb 2023 |
| STI Pharma LLC100 mg, 400 mg · NDC 54879-001, 54879-002 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Ethambutol 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:
50090-2337,50090-3948,50090-5142 - American Health Packaging:
68084-280 - Carilion Materials Management:
68151-0149 - Department of State Health Services, Pharmacy Branch:
55695-023,55695-035 - Physicians Total Care, Inc.:
54868-6219,54868-2876 - Remedyrepack Inc.:
70518-3662,70518-2966 - State of Florida DOH Central Pharmacy:
53808-0977
Recalls
- Feb 22, 2013 · Class III · Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.