Angiotensin 2 Receptor Blocker, Thiazide Diuretic
Where is Hydrochlorothiazide and Losartan made?
13 companies sell it under their own name and 21 repackagers rebottle it. Their labels name 13 factories in India, China and Bangladesh.
India 10China 2Bangladesh 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Aurobindo Pharma Limited25 mg / 100 mg, 50 mg / 12.5 mg, 100 mg / 12.5 mg · NDC 65862-469, 65862-470, 65862-468 | Apl Healthcare LimitedMakes it and tests it | Mahabubnagar, India | No problems foundJan 2023 |
| Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Problems found, fixed voluntarilyJul 2023 | |
| Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 | |
| Alembic Pharmaceuticals Inc.25 mg / 100 mg, 50 mg / 12.5 mg, 100 mg / 12.5 mg · NDC 62332-049, 62332-050, 62332-048 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals LimitedMakes it | Vadodara, India | Problems found, fixed voluntarilyNov 2024 | |
| Alembic Pharmaceuticals Limited25 mg / 100 mg, 50 mg / 12.5 mg, 100 mg / 12.5 mg · NDC 46708-449, 46708-450, 46708-448 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals LimitedMakes it | Vadodara, India | Problems found, fixed voluntarilyNov 2024 | |
| Lupin Pharmaceuticals, Inc.25 mg / 100 mg, 50 mg / 12.5 mg, 100 mg / 12.5 mg · NDC 68180-216, 68180-217, 68180-215 | Lupin LimitedMakes it and packages it | Salcette, India | Problems found, fixed voluntarilyNov 2025 |
| Lupin LimitedMakes it and packages it | Pithampur, India | Serious problems, FDA actionJul 2025 | |
| Solco Healthcare U.S., LLC25 mg / 100 mg, 50 mg / 12.5 mg, 100 mg / 12.5 mg · NDC 43547-425, 43547-424, 43547-423 | 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 | |
| Camber Pharmaceuticals Inc.25 mg / 100 mg, 50 mg / 12.5 mg, 100 mg / 12.5 mg · NDC 31722-756, 31722-757, 31722-755 | Hetero Labs LimitedMakes it | Mahabubnagar, India | Problems found, fixed voluntarilyAug 2022 |
| Granules Pharmaceuticals Inc.25 mg / 100 mg, 50 mg / 12.5 mg, 100 mg / 12.5 mg · NDC 70010-188, 70010-189, 70010-187 | Granules India LimitedMakes it, tests it, packages it and labels it | Medchal-Malkajgiri District, India | Problems found, fixed voluntarilyFeb 2020 |
| Jubilant Cadista Pharmaceuticals Inc.25 mg / 100 mg, 50 mg / 12.5 mg, 100 mg / 12.5 mg · NDC 59746-338, 59746-339, 59746-337 | The ACME Laboratories Ltd.Makes it | Dhaka, Bangladesh | Not inspected on record |
| Macleods Pharmaceuticals Limited25 mg / 100 mg, 50 mg / 12.5 mg, 100 mg / 12.5 mg · NDC 33342-051, 33342-052, 33342-050 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | District Solan, India | Problems found, fixed voluntarilyOct 2023 |
| Northstar Rx LLC.25 mg / 100 mg, 50 mg / 12.5 mg, 100 mg / 12.5 mg · NDC 16714-224, 16714-225, 16714-226 | Apl Healthcare LimitedMakes it and tests it | Mahabubnagar, India | No problems foundJan 2023 |
| Organon LLC Hyzaar25 mg / 100 mg, 50 mg / 12.5 mg, 100 mg / 12.5 mg · NDC 78206-140, 78206-141, 78206-139 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.25 mg / 100 mg, 50 mg / 12.5 mg, 100 mg / 12.5 mg · NDC 0093-7369, 0093-7368, 0093-7367 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Unichem Pharmaceuticals (USA), Inc.25 mg / 100 mg, 50 mg / 12.5 mg, 100 mg / 12.5 mg · NDC 29300-191, 29300-192, 29300-190 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Hydrochlorothiazide and Losartan 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:
50090-5295,50090-4305,50090-5960,50090-1745+18 - Aidarex Pharmaceuticals LLC:
33261-950,33261-904,33261-838 - Aphena Pharma Solutions - Tennessee, Inc.:
71610-671,43353-926 - AvKARE, Inc.:
42291-503,42291-504,42291-502 - Bryant Ranch Prepack:
72162-1700,72162-2315,71335-2572,72162-2492+12 - Coupler LLC:
67046-1618 - Direct Rx:
61919-785,61919-797,61919-732,72189-098+14 - Dispensing Solutions Inc.:
68258-6031,68258-6040 - Lake Erie Medical DBA Quality Care Products LLC:
83008-086 - Legacy Pharmaceutical Packaging:
68645-412 - MedVantx, Inc.:
66116-450 - NuCare Pharmaceuticals.Inc.:
68071-1947,68071-4159,68071-4518,68071-2785 - PD-Rx Pharmaceuticals, Inc.:
72789-162,43063-986 - Physicians Total Care, Inc.:
54868-6108,54868-5705,54868-6109,54868-4341+2 - Preferred Pharmaceuticals, Inc..:
68788-8632,68788-6452,68788-8187 - Proficient Rx LP:
63187-918,63187-727,82804-103,63187-602+5 - QPharma, Inc.:
42708-193,42708-036 - Rebel Distributors Corp..:
21695-966,21695-788,21695-831 - Remedyrepack Inc.:
70518-3398,70518-2737,70518-3420,70518-3404 - St. Mary's Medical Park Pharmacy:
60760-572 - Stat Rx USA:
16590-954
Recalls
- May 7, 2024 · Class II · Macleods Pharma Usa, Inc
Presence of foreign substance: plastic-like substance. - Jun 10, 2022 · Class II · Macleods Pharma Usa Inc
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits - May 11, 2022 · Class II · Direct Rx · 3 recall notices
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . - May 5, 2022 · Class II · Direct Rx
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits - Apr 15, 2022 · Class II · Macleods Pharma Usa Inc · 3 recall notices
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits - Mar 31, 2022 · Class II · Lupin Pharmaceuticals Inc. · 3 recall notices
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits - Jun 20, 2019 · Class II · Macleods Pharma Usa Inc · 3 recall notices
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. - Mar 12, 2019 · Class II · Direct Rx
CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API. - Jul 11, 2014 · Class II · Jubilant Cadista Pharmaceuticals Inc.
Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.