alpha-Adrenergic Agonist
Where is Brimonidine made?
18 companies sell it under their own name and 4 repackagers rebottle it. Their labels name 8 factories in India, the United States and Canada.
India 6United States 1Canada 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Florida Pharmaceutical Products, LLC.2 mg per 1 mg · NDC 71921-185 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Indoco Remedies LimitedMakes it, tests it, packages it and labels it | Goa, India | Serious problems, FDA actionFeb 2023 | |
| Akorn2 mg per 1 mL · NDC 17478-715 | AkornMakes it, tests it and sterilizes it | Location not on file | Not inspected on record |
| Alembic Pharmaceuticals Inc.1 mg per 1 mL, 1.5 mg per 1 mL · NDC 62332-749, 62332-661 | Alembic Pharmaceuticals LimitedMakes it | Vadodara, India | Problems found, fixed voluntarilyFeb 2026 |
| Alembic Pharmaceuticals Limited1 mg per 1 mL, 1.5 mg per 1 mL · NDC 46708-749, 46708-661 | Alembic Pharmaceuticals LimitedMakes it | Vadodara, India | Problems found, fixed voluntarilyFeb 2026 |
| Bausch & Lomb Incorporated2 mg per 1 mL · NDC 24208-411 | Bausch & Lomb IncorporatedMakes it | Tampa, FL, United States | Serious problems, FDA actionMar 2026 |
| Galderma Laboratories, L.P. Mirvaso5 mg per 1 g · NDC 0299-5980 | G Production IncMakes it | Baie D'Urfe, Canada | No problems foundFeb 2023 |
| Gland Pharma Limited1 mg per 1 mL · NDC 68083-626 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Indoco Remedies Limited2 mg per 1 mg · NDC 14445-400 | Indoco Remedies LimitedMakes it and tests it | Goa, India | Serious problems, FDA actionFeb 2023 |
| Lifestar Pharma LLC.1 mg per 1 mL · NDC 70756-677, 70756-678, 70756-679 | Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 |
| Micro Labs Limited1 mg per 1 mL, 2 mg per 1 mL · NDC 42571-462, 42571-419 | Micro Labs LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Problems found, fixed voluntarilyJun 2026 |
| Sincerus Florida, LLC0.25 g per 100 g · NDC 72934-1027 | Sincerus Florida, LLCMakes it | Location not on file | Not inspected on record |
| Somerset Therapeutics, LLC1 mg per 1 mL, 2 mg per 1 mL · NDC 70069-566, 70069-567, 70069-568 +3 | Somerset Therapeutics Private LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Serious problems, FDA actionFeb 2025 |
| Allergan, Inc. Alphagan P1 mg per 1 mL, 1.5 mg per 1 mL · NDC 0023-9321, 0023-9177 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Apotex Corp.1 mg per 1 mL, 1.5 mg per 1 mL · NDC 60505-0577, 60505-0564 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Pacific Pharma, Inc.1 mg per 1 mL, 1.5 mg per 1 mL · NDC 82182-321, 82182-773 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis Israel Pharmaceuticals Ltd5 mg per 1 g · NDC 45802-078 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc. Brimonidine Tartrate1 mg per 1 mL, 1.5 mg per 1 mL, 2 mg per 1 mL · NDC 0781-7177, 61314-144, 61314-143 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Upsher-Smith Laboratories, Inc.1 mg per 1 mL, 1.5 mg per 1 mL · NDC 0832-1435, 0832-1420 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Brimonidine 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:
50090-1800,50090-4224 - Bryant Ranch Prepack:
63629-9616 - Physicians Total Care, Inc.:
54868-4276,54868-6094,54868-4690,54868-6287 - Stat Rx USA:
16590-883
Recalls
- Mar 1, 2023 · Class II · Apotex Corp.
Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility. - Jun 4, 2020 · Class III · Somerset Therapeutics Llc · 3 recall notices
Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.