Atypical Antipsychotic
Where is Quetiapine made?
26 companies sell it under their own name and 31 repackagers rebottle it. Their labels name 22 factories in India, China, the United States and Belgium.
India 14China 4United States 3Belgium 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| BluePoint Laboratories.25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 300 mg · NDC 68001-184, 68001-599, 68001-600 +8 | Lupin LimitedMakes it | Salcette, India | Problems found, fixed voluntarilyNov 2025 |
| Lupin LimitedMakes it | Pithampur, India | Serious problems, FDA actionJul 2025 | |
| Unichem Laboratories LimitedMakes it, tests it, packages it and labels it | Bardez, India | Problems found, fixed voluntarilyJul 2024 | |
| Camber Pharmaceuticals Inc.25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg · NDC 31722-766, 31722-767, 31722-764 +3 | Evaric Pharmaceuticals IncMakes it and tests it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2025 |
| Hetero Labs LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 | |
| Hetero Labs LimitedMakes it | Mahabubnagar, India | Problems found, fixed voluntarilyAug 2022 | |
| Accord Healthcare Inc.25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 300 mg · NDC 16729-147, 16729-109, 16729-148 +8 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | No problems foundJul 2024 |
| Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | Serious problems, FDA actionDec 2022 | |
| Ascend Laboratories, LLC25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 300 mg · NDC 67877-250, 67877-245, 67877-246 +4 | Alkem Laboratories LimitedMakes it, tests it and packages it | Amaliya Daman, India | No problems foundAug 2019 |
| Alkem Laboratories LimitedMakes it, tests it and packages it | Baddi Solan, India | Problems found, fixed voluntarilyMar 2024 | |
| Aurobindo Pharma Limited25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 300 mg · NDC 65862-491, 65862-874, 65862-492 +9 | 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 | |
| Lupin Pharmaceuticals, Inc.25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 300 mg · NDC 68180-447, 68180-613, 68180-614 +8 | 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 | |
| Quallent Pharmaceuticals Health LLC25 mg, 50 mg, 100 mg, 200 mg · NDC 82009-097, 82009-098, 82009-095 +1 | 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 | |
| SpecGx LLC50 mg, 150 mg, 200 mg, 300 mg, 400 mg · NDC 0406-1181, 0406-1182, 0406-1183 +2 | IntelliPharmaCeutics Corp.Makes it and packages it | Location not on file | Not inspected on record |
| Zhejiang SyncoTide Bio-pharmaceutical Co., LtdMakes the active ingredient | Shaoxing, China | Problems found, fixed voluntarilyMar 2025 | |
| ACI Healthcare USA, Inc.50 mg, 150 mg, 200 mg, 300 mg, 400 mg · NDC 71093-136, 71093-137, 71093-138 +2 | ScieGen Pharmaceuticals, INC.Makes it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 |
| Alembic Pharmaceuticals Limited25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg · NDC 46708-136, 46708-137, 46708-134 +3 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| AlignScience Pharma Inc.150 mg, 200 mg · NDC 69948-002, 69948-003 | Haimen Pharma Inc.Makes it, tests it, packages it and labels it | Nantong, China | Problems found, fixed voluntarilyAug 2023 |
| Caraco Pharmaceutical Laboratories, Ltd.25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg · NDC 47335-904, 47335-905, 47335-902 +3 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Dadra, India | Problems found, fixed voluntarilyMar 2019 |
| H2-Pharma LLC Seroquel, Seroquelxr25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 300 mg · NDC 61269-252, 61269-271, 61269-253 +8 | Ajinomoto OmnichemMakes the active ingredient | Wetteren, Belgium | Problems found, fixed voluntarilyJun 2025 |
| Hikma Pharmaceuticals USA Inc.25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg · NDC 0054-0221, 0054-0222, 0054-0220 +3 | West-Ward Columbus Inc.Makes it | Columbus, OH, United States | No problems foundApr 2026 |
| Ingenus Pharmaceuticals, LLC50 mg, 150 mg, 200 mg, 300 mg, 400 mg · NDC 50742-636, 50742-637, 50742-638 +2 | Novast Laboratories Ltd.Makes it, tests it, packages it and labels it | Nantong, China | Problems found, fixed voluntarilyJul 2023 |
| Macleods Pharmaceuticals Limited25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 300 mg · NDC 33342-101, 33342-134, 33342-103 +7 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Daman, India | Problems found, fixed voluntarilyMay 2023 |
| Northstar Rx LLC.25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg · NDC 16714-377, 16714-378, 16714-375 +3 | Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Problems found, fixed voluntarilyJul 2023 |
| Rising Pharma Holdings, Inc.25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 300 mg · NDC 16571-719, 16571-809, 16571-720 +4 | Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Problems found, fixed voluntarilyJul 2023 |
| ScieGen Pharmaceuticals, Inc.50 mg, 150 mg, 200 mg, 300 mg, 400 mg · NDC 50228-381, 50228-382, 50228-383 +2 | ScieGen Pharmaceuticals, INC.Makes it and tests it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 |
| Solco Healthcare U.S., LLC25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 300 mg · NDC 43547-520, 43547-020, 43547-021 +8 | Zhejiang Huahai Pharmaceutical Co., Ltd.Makes it | Linhai, China | Serious problems, FDA actionApr 2026 |
| Unichem Pharmaceuticals (USA), Inc.25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 300 mg · NDC 29300-149, 29300-309, 29300-310 +8 | Unichem Laboratories LimitedMakes it, tests it, packages it and labels it | Bardez, India | Problems found, fixed voluntarilyJul 2024 |
| XLCare Pharmaceuticals, Inc.25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg · NDC 72865-266, 72865-267, 72865-264 +3 | Evaric Pharmaceuticals IncMakes it and tests it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2025 |
| AstraZeneca Pharmaceuticals LP Seroquel, Seroquelxr25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 300 mg · NDC 0310-0271, 0310-0281, 0310-0272 +8 | The label doesn't name the factory. Plants this company names for other drugs | ||
| AvPAK25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg · NDC 50268-632, 50268-633, 50268-630 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Novast Laboratories, Ltd.150 mg, 200 mg, 300 mg, 400 mg · NDC 34908-636, 34908-637, 34908-638 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg · NDC 0093-8162, 0093-8163, 0093-2063 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Quetiapine 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:
50090-2689,50090-5884,50090-3377,50090-6812+17 - Advanced Rx Pharmacy of Tennessee, LLC:
80425-0413,80425-0186,80425-0184 - American Health Packaging:
60687-349,60687-360,60687-327,60687-371+2 - Aphena Pharma Solutions - Tennessee, Inc.:
43353-785,43353-818,43353-155,71610-136+15 - Asclemed USA, Inc.:
76420-514,76420-516,76420-518,76420-512+3 - Avera McKennan Hospital:
69189-0484,69189-0580,69189-0495 - Bryant Ranch Prepack:
71335-2428,63629-4776,71335-2333,71335-1462+23 - Cardinal Health 107, LLC:
55154-7894,55154-3359,55154-7881,55154-8092 - Carilion Materials Management:
68151-5225 - Coupler Enterprises Inc.:
67046-662,67046-636,67046-620,67046-632+10 - Coupler LLC:
67046-0632,67046-0636,67046-0487,67046-1623+8 - Denton Pharma, Inc. DBA Northwind Pharmaceuticals.:
70934-185 - Direct Rx:
72189-340,72189-586,72189-481,72189-519+9 - Golden State Medical Supply, Inc.:
51407-068,51407-800,51407-069,51407-801+7 - Major Pharmaceuticals:
0904-6640,0904-6802,0904-6803,0904-6641+7 - Marlex Pharmaceuticals, Inc.:
10135-656,10135-657,10135-658,10135-659 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8472,0615-8473,0615-8470,0615-8474+2 - NuCare Pharmaceuticals.Inc.:
68071-2158,68071-1892,68071-2712,68071-3931+7 - PD-Rx Pharmaceuticals, Inc.:
72789-255,72789-266 - Physicians Total Care, Inc.:
54868-4257,54868-6338,54868-6341,54868-4961+6 - Preferred Pharmaceuticals, Inc..:
68788-8745,68788-8859,68788-8746,68788-8823+4 - Proficient Rx LP:
63187-269,82804-020,82804-094,71205-401+7 - RPK Pharmaceuticals, Inc.:
53002-1516,53002-2516,53002-1529,53002-2529 - Rebel Distributors Corp..:
21695-119,21695-120,21695-117,21695-118 - RedPharm Drug. Inc.:
67296-1336,67296-1582,67296-1243,67296-1394 - Remedyrepack Inc.:
70518-3429,70518-2102,70518-4701,70518-4051+16 - St. Mary's Medical Park Pharmacy:
60760-762,60760-866,60760-763,60760-764 - Stat Rx USA:
16590-520,16590-782,42549-674 - TYA Pharmaceuticals:
64725-0147,64725-0281,64725-0148,64725-0282+6 - Unit Dose Services:
50436-6338,50436-6339 - Unit Dose Solutions, Inc.:
87441-072,87441-073,87441-074,87441-071
Recalls
- Feb 27, 2020 · Class III · The Harvard Drug Group · 4 recall notices
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets. - Nov 14, 2018 · Class II · Ascend Laboratories LLC
Presence of Foreign Substance; metal shard found in tablet
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.