beta-Adrenergic Blocker
Where is Timolol made?
29 companies sell it under their own name and 4 repackagers rebottle it. Their labels name 17 factories in India, France, the United States, Switzerland and Germany.
India 9France 3United States 3Switzerland 1Germany 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Alembic Pharmaceuticals Inc.2.5 mg per 1 mL, 5 mg per 1 mL · NDC 62332-545, 62332-546 | Alembic Pharmaceuticals LimitedMakes it | Vadodara, India | Problems found, fixed voluntarilyFeb 2026 |
| Gland Pharma LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 | |
| Bausch & Lomb Americas Inc.2.5 mg per 1 mL, 5 mg per 1 mL, 6.8 mg per 1 mL · NDC 82260-812, 82260-818, 82260-045 +3 | Bausch & Lomb IncorporatedMakes it | Tampa, FL, United States | Serious problems, FDA actionMar 2026 |
| Laboratoire UnitherMakes it | Coutances, France | Problems found, fixed voluntarilyOct 2021 | |
| Bausch & Lomb Incorporated Timoptic-XE, Timoptic, Timoptic in Ocudose, Istalol2.5 mg per 1 mL, 3.4 mg per 1 mL, 5 mg per 1 mL, 6.8 mg per 1 mL · NDC 24208-814, 24208-812, 24208-498 +4 | Bausch & Lomb IncorporatedMakes it | Tampa, FL, United States | Serious problems, FDA actionMar 2026 |
| Laboratoire UnitherMakes it | Coutances, France | Problems found, fixed voluntarilyOct 2021 | |
| Northstar Rx LLC.2.5 mg per 1 mL, 5 mg per 1 mL · NDC 72603-162, 72603-163, 72603-540 | Dr.reddy's Laboratories LimitedMakes it and tests it | Visakhapatnam, India | Problems found, fixed voluntarilyMay 2024 |
| Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 | |
| Rising Pharma Holdings, Inc.2.5 mg per 1 mL, 5 mg, 5 mg per 1 mL, 10 mg, 20 mg · NDC 16571-224, 64980-513, 16571-225 +2 | FDC LimitedMakes it and tests it | Chhatrapati Sambhajinagar, India | No problems foundFeb 2023 |
| InvaTech Pharma Solutions LLCMakes it, tests it, packages it and labels it | East Brunswick, NJ, United States | Problems found, fixed voluntarilyMay 2026 | |
| Akorn2.5 mg per 1 mL, 5 mg per 1 mL · NDC 17478-289, 17478-288 | AkornMakes it, tests it, packages it, labels it and sterilizes it | Location not on file | Not inspected on record |
| Akorn Betimol2.56 mg per 1 mL, 5.12 mg per 1 mL · NDC 76478-001, 76478-002 | Ophtapharm AGMakes it, tests it, packages it and labels it | Hettlingen, Switzerland | Problems found, fixed voluntarilyFeb 2020 |
| Akorn5.0 mg per 1 mL · NDC 17478-189 | ExcelvisionMakes it | Annonay, France | Serious problems, FDA actionJan 2026 |
| Alembic Pharmaceuticals Limited2.5 mg per 1 mL, 5 mg per 1 mL · NDC 46708-545, 46708-546 | Alembic Pharmaceuticals LimitedMakes it | Vadodara, India | Problems found, fixed voluntarilyFeb 2026 |
| Armas Pharmaceuticals Inc.6.8 mg per 1 mL · NDC 72485-602 | Rommelag CDMO GmbHMakes it, packages it and labels it | Sulzbach-Laufen, Germany | Problems found, fixed voluntarilyMar 2025 |
| Aurobindo Pharma Limited5 mg per 1 mL · NDC 59651-313 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| Caplin Steriles Limited5 mg per 1 mL · NDC 65145-152, 65145-153, 65145-154 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| Dr. Reddy's Laboratories Inc.2.5 mg per 1 mL, 5 mg per 1 mL · NDC 43598-747, 43598-748 | Dr.reddy's Laboratories LimitedMakes it and tests it | Visakhapatnam, India | Problems found, fixed voluntarilyMay 2024 |
| FDC Limited2.5 mg per 1 mL, 5 mg per 1 mL · NDC 55545-1000, 55545-1001 | FDC LimitedMakes it and tests it | Chhatrapati Sambhajinagar, India | No problems foundFeb 2023 |
| First Nation Group, LLC2.5 mg per 1 mL, 5 mg per 1 mL · NDC 81469-209, 81469-210 | Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 |
| Gland Pharma Limited2.5 mg per 1 mL, 5 mg per 1 mL · NDC 68083-457, 68083-458 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| H.J. Harkins Co., Inc.0.1 mg per 1 mL · NDC 76519-1163 | H.J. Harkins Company, Inc.Makes it, repackages it and relabels it | Grover Beach, California, United States | Problems found, fixed voluntarilyMar 2023 |
| Ingenus Pharmaceuticals, LLC3.4 mg per 1 mL, 6.8 mg per 1 mL · NDC 50742-287, 50742-288 | Kaysersberg PharmaceuticalsMakes it, tests it, packages it and labels it | Kaysersberg-Vignoble, France | Problems found, fixed voluntarilyMay 2024 |
| Leading Pharma, LLC5 mg per 1 mL · NDC 69315-325 | Caplin Steriles LimitedMakes it | Gummidipoondi, India | No problems foundAug 2024 |
| Lifestar Pharma LLC.2.5 mg per 1 mL, 5 mg per 1 mL · NDC 70756-654, 70756-655, 70756-656 +1 | Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 |
| Micro Labs Limited2.5 mg per 1 mL, 5 mg per 1 mL, 6.8 mg per 1 mL · NDC 42571-403, 42571-404, 42571-398 | Micro Labs LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Problems found, fixed voluntarilyJun 2026 |
| Nordic Pharma, Inc.5 mg per 1 mL · NDC 69918-601 | Rommelag CDMO GmbHMakes it and packages it | Sulzbach-Laufen, Germany | Problems found, fixed voluntarilyMar 2025 |
| Somerset Therapeutics, LLC2.5 mg per 1 mL, 5 mg per 1 mL · NDC 70069-701, 70069-702, 70069-703 +10 | Somerset Therapeutics Private LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Serious problems, FDA actionFeb 2025 |
| Fosun Pharma USA Inc.2.5 mg per 1 mL, 5 mg per 1 mL · NDC 72266-199, 72266-200 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.5 mg, 10 mg, 20 mg · NDC 0378-0221, 0378-0715, 0378-0055 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Pacific Pharma, Inc.2.5 mg per 1 mL, 5 mg per 1 mL · NDC 60758-802, 60758-801 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals2.5 mg per 1 mL, 5 mg per 1 mL · NDC 25021-008, 25021-009 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc. Timolol GFS2.5 mg per 1 mL, 5 mg per 1 mL · NDC 61314-224, 61314-226, 61314-225 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Thea Pharma Inc. Betimol2.56 mg per 1 mL, 5.12 mg per 1 mL · NDC 82584-001, 82584-002 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Timolol 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:
50090-5091,50090-5769,50090-3441,50090-7837+1 - Avera McKennan Hospital:
69189-0496 - Medsource Pharmaceuticals:
45865-121 - Physicians Total Care, Inc.:
54868-3713,54868-3714,54868-4691
Recalls
- Jul 5, 2025 · Class II · FDC Limited
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle. - Apr 18, 2025 · Class II · FDC Limited
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. - Jan 23, 2025 · Class II · FDC Limited
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. - Dec 5, 2024 · Class II · FDC Limited
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. - Oct 29, 2024 · Class II · FDC Limited
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle - Aug 12, 2024 · Class II · FDC Limited
Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. - Jul 18, 2024 · Class II · FDC Limited
Defective container; yellow colored spike from cap lodged in the nozzle - Apr 25, 2024 · Class II · FDC Limited
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers. - Mar 5, 2024 · Class II · Thea Pharma, Inc.
Lack of Assurance of Sterility: Out of specification for volume and compromised container closure. - Oct 13, 2022 · Class II · Akorn, Inc.
CGMP Deviations: - Aug 8, 2022 · Class III · Akorn, Inc
Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point. - Nov 15, 2019 · Class III · Rising Pharmaceuticals, Inc. · 2 recall notices
Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.