Anticholinergic
Where is Tropicamide made?
5 companies sell it under their own name and 1 repackager rebottle it. Their labels name 3 factories in the United States and India.
United States 2India 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Akorn5 mg per 1 mL, 10 mg per 1 mL · NDC 17478-102, 17478-101 | AkornMakes it, tests it and sterilizes it | Location not on file | Not inspected on record |
| Alcon Laboratories, Inc.10 mg per 1 mL · NDC 0998-0355 | Alcon Research LLCMakes it | Fort Worth, TX, United States | No problems foundSep 2022 |
| Bausch & Lomb Incorporated5 mg per 1 mL, 10 mg per 1 mL · NDC 24208-585, 24208-590 | Bausch & Lomb IncorporatedMakes it | Tampa, FL, United States | Serious problems, FDA actionMar 2026 |
| Sandoz Inc.5 mg per 1 mL, 10 mg per 1 mL · NDC 61314-355, 61314-354 | Alcon Research LLCMakes it | Fort Worth, TX, United States | No problems foundSep 2022 |
| Somerset Therapeutics, LLC10 mg per 1 mL · NDC 70069-121 | Somerset Therapeutics Private LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Serious problems, FDA actionFeb 2025 |
Repackaged by
These companies buy Tropicamide 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.
Recalls
- Jan 18, 2016 · Class III · Bausch & Lomb, Inc. · 2 recall notices
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.