Angiotensin 2 Receptor Blocker, Thiazide Diuretic
Where is Hydrochlorothiazide and Valsartan made?
13 companies sell it under their own name and 10 repackagers rebottle it. Their labels name 10 factories in India, the United States and China.
India 6United States 2China 2
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Macleods Pharmaceuticals Limited25 mg / 160 mg, 25 mg / 320 mg, 80 mg / 12.5 mg, 160 mg / 12.5 mg, 320 mg / 12.5 mg · NDC 33342-075, 33342-076, 33342-078 +2 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | District Solan, India | Problems found, fixed voluntarilyOct 2023 |
| Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Daman, India | Problems found, fixed voluntarilyMay 2023 | |
| Solco Healthcare U.S., LLC25 mg / 160 mg, 25 mg / 320 mg, 80 mg / 12.5 mg, 160 mg / 12.5 mg, 320 mg / 12.5 mg · NDC 43547-312, 43547-313, 43547-315 +2 | Zhejiang Huahai Pharmaceutical Co., Ltd.Makes it | Linhai, China | Serious problems, FDA actionApr 2026 |
| Zhejiang Huahai Pharmaceutical Technology Co., Ltd.Makes it | Taizhou, China | Problems found, fixed voluntarilyAug 2025 | |
| Alembic Pharmaceuticals Inc.25 mg / 160 mg, 25 mg / 320 mg, 80 mg / 12.5 mg, 160 mg / 12.5 mg, 320 mg / 12.5 mg · NDC 62332-080, 62332-081, 62332-083 +2 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited25 mg / 160 mg, 25 mg / 320 mg, 80 mg / 12.5 mg, 160 mg / 12.5 mg, 320 mg / 12.5 mg · NDC 46708-454, 46708-455, 46708-457 +2 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Amneal Pharmaceuticals25 mg / 160 mg, 25 mg / 320 mg, 80 mg / 12.5 mg, 160 mg / 12.5 mg, 320 mg / 12.5 mg · NDC 53746-846, 65162-846, 53746-847 +7 | Amneal Pharmaceuticals of New York, LLCMakes it, tests it, packages it and labels it | Brookhaven, NY, United States | No problems foundSep 2026 |
| Aurobindo Pharma Limited25 mg / 160 mg, 25 mg / 320 mg, 80 mg / 12.5 mg, 160 mg / 12.5 mg, 320 mg / 12.5 mg · NDC 65862-548, 65862-549, 65862-551 +2 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Cadila Healthcare Limited25 mg / 160 mg, 25 mg / 320 mg, 80 mg / 12.5 mg, 160 mg / 12.5 mg, 320 mg / 12.5 mg · NDC 70771-1486, 70771-1487, 70771-1489 +2 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Golden State Medical Supply, Inc.25 mg / 160 mg, 25 mg / 320 mg, 80 mg / 12.5 mg, 160 mg / 12.5 mg, 320 mg / 12.5 mg · NDC 84677-073, 84677-074, 84677-076 +2 | ScieGen Pharmaceuticals, INC.Makes it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 |
| Lupin Pharmaceuticals, Inc.25 mg / 160 mg, 25 mg / 320 mg, 80 mg / 12.5 mg, 160 mg / 12.5 mg, 320 mg / 12.5 mg · NDC 68180-104, 68180-105, 68180-102 +2 | Lupin LimitedMakes it and packages it | Salcette, India | Problems found, fixed voluntarilyNov 2025 |
| ScieGen Pharmaceuticals, Inc.25 mg / 160 mg, 25 mg / 320 mg, 80 mg / 12.5 mg, 160 mg / 12.5 mg, 320 mg / 12.5 mg · NDC 50228-148, 50228-149, 50228-151 +2 | ScieGen Pharmaceuticals, INC.Makes it and tests it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 |
| AvKARE, Inc.25 mg / 160 mg, 25 mg / 320 mg, 80 mg / 12.5 mg, 160 mg / 12.5 mg, 320 mg / 12.5 mg · NDC 42291-966, 42291-967, 42291-969 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.25 mg / 160 mg, 25 mg / 320 mg, 80 mg / 12.5 mg, 160 mg / 12.5 mg, 320 mg / 12.5 mg · NDC 0378-6322, 0378-6323, 0378-6325 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Novartis Pharmaceuticals Corporation Diovan HCT25 mg / 160 mg, 25 mg / 320 mg, 80 mg / 12.5 mg, 160 mg / 12.5 mg, 320 mg / 12.5 mg · NDC 0078-0315, 0078-0383, 0078-0472 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Hydrochlorothiazide and Valsartan 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:
50090-1412,50090-6232,50090-1763,50090-4872+15 - Aphena Pharma Solutions - Tennessee, Inc.:
71610-327 - Bryant Ranch Prepack:
71335-2617,71335-2633,63629-7194,71335-2200+6 - Direct Rx:
61919-790,61919-634 - Dispensing Solutions Inc.:
68258-6972,68258-6095,68258-6053,68258-6973+3 - Northwind Pharmaceuticals:
51655-389,51655-698,82868-054,51655-243+1 - Physicians Total Care, Inc.:
54868-4428,54868-5323,54868-5607,54868-5780+2 - Proficient Rx LP:
63187-312,71205-258,71205-015,63187-694+6 - RPK Pharmaceuticals, Inc.:
53002-2786,53002-1785,53002-2785,53002-2784+5 - Stat Rx USA:
16590-312
Recalls
- Dec 31, 2018 · Class II · Aurobindo Pharma USA Inc. · 5 recall notices
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. - Dec 4, 2018 · Class II · Mylan Laboratories Limited, (Nashik FDF) · 5 recall notices
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. - Nov 20, 2018 · Class II · Mylan Pharmaceuticals Inc.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. - Jul 13, 2018 · Class II · Prinston Pharmaceutical Inc · 5 recall notices
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.