5-Lipoxygenase Inhibitor
Where is Zileuton made?
6 companies sell it under their own name and 1 repackager rebottle it. Their labels name 4 factories in India and the United States.
India 3United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Camber Pharmaceuticals Inc.600 mg · NDC 31722-044 | Annora Pharma Private LimitedMakes it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Lupin Pharmaceuticals, Inc.600 1 · NDC 68180-169 | Lupin LimitedMakes it and packages it | Nagpur, India | Problems found, fixed voluntarilyJul 2023 |
| Northstar Rx LLC.600 mg · NDC 72603-246 | Annora Pharma Private LimitedMakes it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Rising Pharma Holdings, Inc.600 mg · NDC 64980-206 | Cohance Lifesciences LimitedMakes it | Medchal-Malkajgiri, India | Problems found, fixed voluntarilyAug 2019 |
| Strides Pharma Science Limited600 mg · NDC 64380-189 | Strides Pharma, IncMakes it, tests it and packages it | Chestnut Ridge, NY, United States | Problems found, fixed voluntarilyFeb 2022 |
| Chiesi USA, Inc. Zyflo600 mg · NDC 10122-901 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Zileuton 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.
- Golden State Medical Supply, Inc.:
51407-741
Recalls
- Jun 10, 2022 · Class II · Lupin Pharmaceuticals Inc.
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.