Corticosteroid
Where is Loteprednol made?
11 companies sell it under their own name and 3 repackagers rebottle it. Their labels name 5 factories in India, Switzerland and the United States.
India 3Switzerland 1United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Akorn5 mg per 1 mL · NDC 50383-265 | AkornMakes it | Location not on file | Not inspected on record |
| Amneal Pharmaceuticals2 mg per 1 mL, 5 mg per 1 mL · NDC 60219-1366, 60219-1367, 60219-1362 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and sterilizes it | Ahmedabad, India | No problems foundJun 2024 |
| Armas Pharmaceuticals Inc.2 mg per 1 mL, 5 mg per 1 g, 5 mg per 1 mL · NDC 72485-653, 72485-630, 72485-665 | Ophtapharm AGMakes it, tests it, packages it and labels it | Hettlingen, Switzerland | Problems found, fixed voluntarilyFeb 2020 |
| Bausch & Lomb Americas Inc.2 mg per 1 mL, 5 mg per 1 g, 5 mg per 1 mL · NDC 82260-361, 82260-508, 82260-299 | Bausch & Lomb IncorporatedMakes it and packages it | Tampa, FL, United States | Serious problems, FDA actionMar 2026 |
| Bausch & Lomb Incorporated Alrex, Lotemax SM, Lotemax2 mg per 1 mL, 3.8 mg per 1 g, 5 mg per 1 g, 5 mg per 1 mL · NDC 24208-353, 24208-507, 24208-443 +2 | Bausch & Lomb IncorporatedMakes it, packages it and labels it | Tampa, FL, United States | Serious problems, FDA actionMar 2026 |
| Caraco Pharmaceutical Laboratories, Ltd.5 mg per 1 mL · NDC 62756-232 | Sun Pharmaceutical Industries Limited (formerly known as Sun Pharmaceutical Medicare Limited)Makes it and tests it | Halol Panchmahal, India | No problems foundFeb 2024 |
| Lupin Pharmaceuticals, Inc.5 mg per 1 mL · NDC 70748-300 | Lupin LimitedMakes it and packages it | Pithampur, India | Serious problems, FDA actionJul 2025 |
| Northstar Rx LLC.5 mg per 1 mL · NDC 72603-324 | Sun Pharmaceutical Industries Limited (formerly known as Sun Pharmaceutical Medicare Limited)Makes it and tests it | Halol Panchmahal, India | No problems foundFeb 2024 |
| Sentiss Pharmaceuticals LLC2 mg per 1 mL, 5 mg per 1 g, 5 mg per 1 mL · NDC 70244-035, 70244-036, 70244-034 | Ophtapharm AGMakes it, tests it, packages it and labels it | Hettlingen, Switzerland | Problems found, fixed voluntarilyFeb 2020 |
| Alcon Laboratories, Inc. Eysuvis2.5 mg per 1 mL · NDC 71571-333 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis US LLC2 mg per 1 mL, 5 mg per 1 mL · NDC 0574-4080, 0574-4135 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Loteprednol 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.
- Physicians Total Care, Inc.:
54868-4277 - Sportpharm LLC:
85766-193 - Stat Rx USA:
16590-007
Recalls
- Jul 5, 2023 · Class III · Sun Pharmaceutical Industries Inc
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content. - Jun 17, 2019 · Class III · Bausch & Lomb
Failed Stability Specifications: Out of specification for viscosity.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.