Serotonin Reuptake Inhibitor
Where is Paroxetine made?
25 companies sell it under their own name and 34 repackagers rebottle it. Their labels name 19 factories in India, the United States, China, Germany and Australia.
India 7United States 5China 5Germany 1Australia 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Aurolife Pharma LLC10 mg, 20 mg, 30 mg, 40 mg · NDC 13107-154, 13107-155, 13107-156 +1 | Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Problems found, fixed voluntarilyJul 2023 |
| Aurolife Pharma LLCMakes it | Dayton, NJ, United States | Serious problems, FDA actionDec 2021 | |
| Cadila Healthcare Limited10 mg, 20 mg, 30 mg, 40 mg · NDC 65841-097, 65841-098, 65841-099 +1 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Zydus Lifesciences LimitedMakes it | Solan, India | No problems foundMar 2020 | |
| Legacy Pharma USA, Inc. Brisdelle7.5 mg · NDC 83107-027 | Excella GmbH & Co. KGMakes it, makes the active ingredient and tests it | Feucht, Germany | Problems found, fixed voluntarilyOct 2022 |
| Norwich Pharmaceuticals, Inc.Makes it, tests it, packages it and labels it | Norwich, NY, United States | No problems foundMay 2026 | |
| Solco Healthcare U.S., LLC7.5 mg, 10 mg, 20 mg, 30 mg, 40 mg · NDC 43547-347, 43547-348, 43547-349 +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 | |
| Zydus Pharmaceuticals (USA) Inc.10 mg, 20 mg, 30 mg, 40 mg · NDC 68382-097, 68382-098, 68382-099 +1 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Zydus Lifesciences LimitedMakes it and tests it | Solan, India | No problems foundMar 2020 | |
| ANI Pharmaceuticals, Inc.10 mg per 5 mL · NDC 70954-319 | Novitium Pharma LLCMakes it, tests it, packages it and labels it | East Windsor, NJ, United States | No problems foundFeb 2024 |
| Alembic Pharmaceuticals Inc.12.5 mg, 25 mg, 37.5 mg · NDC 62332-766, 62332-767, 62332-768 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited12.5 mg, 25 mg, 37.5 mg · NDC 46708-766, 46708-767, 46708-768 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Aurobindo Pharma Limited10 mg, 20 mg, 30 mg, 40 mg · NDC 65862-154, 65862-155, 65862-156 +1 | Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Problems found, fixed voluntarilyJul 2023 |
| Cadila Pharmaceuticals Limited12.5 mg, 25 mg, 37.5 mg · NDC 71209-094, 71209-095, 71209-096 | Cadila Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | No problems foundSep 2025 |
| Camber Pharmaceuticals Inc.10 mg per 5 mL · NDC 31722-578 | Annora Pharma Private LimitedMakes it and tests it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Lannett Company, Inc.12.5 mg, 25 mg, 37.5 mg · NDC 62175-470, 62175-471, 62175-472 | Lannett Company, LLCMakes it | Seymour, IN, United States | Problems found, fixed voluntarilyOct 2022 |
| Lupin Pharmaceuticals, Inc.12.5 mg, 25 mg, 37.5 mg · NDC 68180-647, 68180-646, 68180-645 | Lupin LimitedMakes it and packages it | Pithampur, India | Serious problems, FDA actionJul 2025 |
| Modavar Pharmaceuticals LLC12.5 mg, 25 mg, 37.5 mg · NDC 72241-029, 72241-030, 72241-031 | Cadila Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | No problems foundSep 2025 |
| New Horizon Rx Group, LLC20 mg · NDC 58517-160 | Alphapharm Pty LtdMakes it | Carole Park, Australia | Problems found, fixed voluntarilyJun 2024 |
| Northstar Rx LLC.10 mg, 20 mg, 30 mg, 40 mg · NDC 16714-181, 16714-182, 16714-183 +1 | Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Problems found, fixed voluntarilyJul 2023 |
| Oxford Pharmaceuticals, LLC10 mg, 20 mg, 30 mg, 40 mg · NDC 69584-671, 69584-672, 69584-673 +1 | Oxford Pharmaceuticals, LLCMakes it | Birmingham, AL, United States | Problems found, fixed voluntarilyNov 2023 |
| Sinotherapeutics Inc.12.5 mg, 25 mg, 37.5 mg · NDC 69986-011, 69986-012, 69986-017 | Haimen Pharma Inc.Makes it, tests it, packages it and labels it | Nantong, China | Problems found, fixed voluntarilyAug 2023 |
| Westminster Pharmaceuticals, LLC12.5 mg, 25 mg, 37.5 mg · NDC 69367-335, 69367-336, 69367-337 | Visum Pharmaceutical Co., Ltd.Makes it | Haikou, China | Problems found, fixed voluntarilySep 2026 |
| Yiling Pharmaceutical, Inc.10 mg, 20 mg, 30 mg, 40 mg · NDC 69117-0024, 69117-0025, 69117-0026 +1 | Yiling Pharmaceutical LtdMakes it | Shijiazhuang, China | Serious problems, FDA actionOct 2024 |
| Apotex Corp. Paxil, Paxil CR10 mg, 12.5 mg, 20 mg, 25 mg, 30 mg, 37.5 mg · NDC 60505-0097, 60505-4517, 60505-1316 +17 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.10 mg, 12.5 mg, 20 mg, 25 mg, 30 mg, 37.5 mg · NDC 62135-541, 62135-425, 62135-542 +4 | The label doesn't name the factory. Plants this company names for other drugs | ||
| International Laboratories, LLC10 mg, 20 mg, 30 mg · NDC 54458-990, 54458-989, 54458-988 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.10 mg, 20 mg, 30 mg, 40 mg · NDC 0378-7001, 0378-7002, 0378-7003 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis US LLC7.5 mg · NDC 0574-0279 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Paroxetine 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:
50090-4838,50090-1296,50090-2143,50090-1297+8 - Advanced Rx Pharmacy of Tennessee, LLC:
80425-0339 - Aidarex Pharmaceuticals LLC:
33261-090,53217-177,33261-091 - American Health Packaging:
68084-044,68084-045,68084-046,68084-047 - Aphena Pharma Solutions - Tennessee, Inc.:
71610-150,71610-204,71610-348,43353-713+7 - Apotheca, Inc.:
12634-248 - Asclemed USA, Inc.:
76420-716,76420-717,76420-718,76420-719 - AvPAK:
50268-640,50268-641,50268-642,50268-643 - Blenheim Pharmacal, Inc.:
10544-433,10544-809 - Bryant Ranch Prepack:
71335-1046,71335-0544,71335-0675,63629-1840+7 - Cardinal Health 107, LLC:
55154-7999 - Coupler Enterprises Inc.:
67046-530,67046-531,67046-532,67046-533 - Coupler LLC:
67046-1013,67046-1391,67046-0846,67046-0446 - Denton Pharma, Inc. DBA Northwind Pharmaceuticals.:
70934-222,70934-661,70934-107 - Direct Rx:
61919-322,72189-492,61919-181,61919-658+3 - Golden State Medical Supply, Inc.:
60429-734,60429-735,60429-736,60429-737 - H.J. Harkins Co., Inc.:
52959-775,52959-776 - Hawaii Repack, Inc.:
85534-0026 - Major Pharmaceuticals:
0904-5676,0904-5677 - MedVantx, Inc.:
66116-434 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8359,0615-7985,0615-8173,0615-8174 - Northwind Pharmaceuticals:
51655-356 - NuCare Pharmaceuticals.Inc.:
68071-1740,68071-3843,68071-2535,68071-5304+3 - PD-Rx Pharmaceuticals, Inc.:
55289-037,72789-379,55289-972,55289-053+1 - Physicians Total Care, Inc.:
54868-5080,54868-4938,54868-5347,54868-6178+7 - Preferred Pharmaceuticals, Inc..:
68788-8829,68788-0797,68788-8777,68788-9074+3 - Proficient Rx LP:
63187-190,71205-527,63187-564,63187-105+3 - RPK Pharmaceuticals, Inc.:
53002-1174,53002-2174 - Rebel Distributors Corp..:
21695-101,21695-159,21695-102,21695-160+2 - Remedyrepack Inc.:
70518-1406,70518-2376,70518-2574,70518-3430+10 - Stat Rx USA:
16590-322,16590-514,16590-181 - State of Florida DOH Central Pharmacy:
53808-0748,53808-0393,53808-0749,53808-0750+9 - TYA Pharmaceuticals:
64725-0097,64725-0197,64725-0083,64725-0098 - Unit Dose Services:
50436-3933
Recalls
- Sep 23, 2026 · Class II · Apotex Corp.
Failed dissolution specifications. - Aug 13, 2026 · Class II · Apotex Corp.
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria - Nov 10, 2023 · Class II · Golden State Medical Supply Inc. · 3 recall notices
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine - Nov 1, 2023 · Class II · Apotex Corp. · 4 recall notices
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine - Nov 20, 2017 · Class II · Zydus Pharmaceuticals USA Inc
Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets - Oct 24, 2017 · Class II · Amerisource Health Services
Presence of Foreign Tablets/Capsules. - Aug 18, 2017 · Class II · Zydus Pharmaceuticals USA Inc
Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets - Jun 22, 2017 · Class III · Lupin Pharmaceuticals Inc.
Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study. - Mar 24, 2014 · Class II · Apotex Inc. · 5 recall notices
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.