Angiotensin 2 Receptor Blocker, Calcium Channel Blocker
Where is Amlodipine and Olmesartan made?
12 companies sell it under their own name and 6 repackagers rebottle it. Their labels name 9 factories in India and the United States.
India 8United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Accord Healthcare Inc.5 mg / 20 mg, 5 mg / 40 mg, 10 mg / 20 mg, 10 mg / 40 mg · NDC 16729-394, 16729-395, 16729-392 +1 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | No problems foundJul 2024 |
| Ajanta Pharma USA Inc.5 mg / 20 mg, 5 mg / 40 mg, 10 mg / 20 mg, 10 mg / 40 mg · NDC 27241-085, 27241-086, 27241-083 +1 | Ajanta Pharma LimitedMakes it | Chhatrapati Sambhajinagar, India | Problems found, fixed voluntarilyApr 2026 |
| Alembic Pharmaceuticals Inc.5 mg / 20 mg, 5 mg / 40 mg, 10 mg / 20 mg, 10 mg / 40 mg · NDC 62332-214, 62332-215, 62332-212 +1 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited5 mg / 20 mg, 5 mg / 40 mg, 10 mg / 20 mg, 10 mg / 40 mg · NDC 46708-214, 46708-215, 46708-212 +1 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Amneal Pharmaceuticals5 mg / 20 mg, 5 mg / 40 mg, 10 mg / 20 mg, 10 mg / 40 mg · NDC 69238-2673, 69238-2674, 69238-2675 +1 | ScieGen Pharmaceuticals, INC.Makes it and tests it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 |
| Ascend Laboratories, LLC5 mg / 20 mg, 5 mg / 40 mg, 10 mg / 20 mg, 10 mg / 40 mg · NDC 67877-500, 67877-502, 67877-499 +1 | Alkem Laboratories LimitedMakes it, tests it and packages it | Baddi Solan, India | Problems found, fixed voluntarilyMar 2024 |
| Aurobindo Pharma Limited5 mg / 20 mg, 5 mg / 40 mg, 10 mg / 20 mg, 10 mg / 40 mg · NDC 65862-856, 65862-857, 65862-854 +1 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Camber Pharmaceuticals Inc.5 mg / 20 mg, 5 mg / 40 mg, 10 mg / 20 mg, 10 mg / 40 mg · NDC 31722-447, 31722-448, 31722-445 +1 | Hetero Labs LimitedMakes it | Mahabubnagar, India | Problems found, fixed voluntarilyAug 2022 |
| Macleods Pharmaceuticals Limited5 mg / 20 mg, 5 mg / 40 mg, 10 mg / 20 mg, 10 mg / 40 mg · NDC 33342-192, 33342-193, 33342-190 +1 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | District Solan, India | Problems found, fixed voluntarilyOct 2023 |
| Micro Labs Limited5 mg / 20 mg, 5 mg / 40 mg, 10 mg / 20 mg, 10 mg / 40 mg · NDC 42571-236, 42571-238, 42571-235 +1 | Micro Labs LimitedMakes it, tests it, packages it and labels it | Verna, India | Problems found, fixed voluntarilyMay 2025 |
| ScieGen Pharmaceuticals, Inc.5 mg / 20 mg, 5 mg / 40 mg, 10 mg / 20 mg, 10 mg / 40 mg · NDC 50228-367, 50228-368, 50228-365 +1 | ScieGen Pharmaceuticals, INC.Makes it and tests it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 |
| Cosette Pharmaceuticals, Inc. Azor5 mg / 20 mg, 5 mg / 40 mg, 10 mg / 20 mg, 10 mg / 40 mg · NDC 0713-0871, 0713-0873, 0713-0870 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Amlodipine and Olmesartan 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:
50090-7863 - AvKARE, Inc.:
42291-003,42291-004,42291-001,42291-002 - Bryant Ranch Prepack:
72162-2379 - Golden State Medical Supply, Inc.:
51407-858,51407-860,51407-857,51407-859 - Medsource Pharmaceuticals:
45865-901,45865-947,45865-923,45865-935 - Physicians Total Care, Inc.:
54868-6250,54868-6036
Recalls
- Oct 6, 2026 · Class II · Ascend Laboratories, LLC
Out of specification due to dissolution. - Jul 8, 2026 · Class II · Ascend Laboratories, LLC
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications - May 5, 2026 · Class II · Ascend Laboratories, LLC
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications - Jul 21, 2025 · Class II · Ascend Laboratories, LLC
Failed Dissolution Specifications: low dissolution results - Feb 15, 2022 · Class II · Macleods Pharma Usa Inc
cGMP deviations - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - Nov 30, 2018 · Class III · Aurobindo Pharma USA Inc.
Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach).
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.