Phenothiazine
Where is Fluphenazine made?
26 companies sell it under their own name and 13 repackagers rebottle it. Their labels name 19 factories in India, the United States, Israel and Taiwan.
India 12United States 5Israel 1Taiwan 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Novadoz Pharmaceuticals LLC1 mg, 2.5 mg, 5 mg, 10 mg, 25 mg per 1 mL · NDC 72205-112, 72205-115, 72205-113 +2 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| MSN Pharmaceuticals IncMakes it and tests it | Piscataway, NJ, United States | No problems foundMar 2026 | |
| ANI Pharmaceuticals, Inc.1 mg, 2.5 mg, 5 mg, 10 mg · NDC 70954-273, 70954-276, 70954-274 +1 | Novitium Pharma LLCMakes it, tests it, packages it and labels it | East Windsor, NJ, United States | No problems foundFeb 2024 |
| Ajanta Pharma USA Inc.1 mg, 2.5 mg, 5 mg, 10 mg · NDC 27241-255, 27241-252, 27241-254 +1 | Ajanta Pharma LimitedMakes it | Bharuch, India | No problems foundJun 2023 |
| Alembic Pharmaceuticals Inc.1 mg, 2.5 mg, 5 mg, 10 mg · NDC 62332-788, 62332-791, 62332-789 +1 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited1 mg, 2.5 mg, 5 mg, 10 mg · NDC 46708-788, 46708-791, 46708-789 +1 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Amneal Pharmaceuticals1 mg, 2.5 mg, 5 mg, 10 mg · NDC 60219-1678, 69238-1678, 60219-1681 +5 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | No problems foundJul 2024 |
| AuroMedics Pharma LLC125 mg per 5 mL · NDC 55150-267 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| Aurobindo Pharma Limited1 mg, 2.5 mg, 5 mg, 10 mg · NDC 59651-686, 59651-689, 59651-687 +1 | Apl Healthcare LimitedMakes it and tests it | Mahabubnagar, India | No problems foundJan 2023 |
| Cadila Healthcare Limited1 mg, 2.5 mg, 5 mg, 10 mg · NDC 70771-1581, 70771-1584, 70771-1582 +1 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Camber Pharmaceuticals Inc.1 mg, 2.5 mg, 5 mg, 10 mg · NDC 31722-384, 31722-387, 31722-385 +1 | Hetero Labs LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 |
| Caraco Pharmaceutical Laboratories, Ltd.1 mg, 2.5 mg, 5 mg, 10 mg · NDC 51672-4233, 51672-4236, 51672-4234 +1 | Taro Pharmaceutical Industries Ltd.Makes it | Haifa Bay, Israel | No problems foundDec 2022 |
| Dr. Reddy's Laboratories Inc.1 mg, 2.5 mg, 5 mg, 10 mg · NDC 43598-034, 43598-037, 43598-035 +1 | Cerovene, Inc.Makes it and tests it | Valley Cottage, NY, United States | Problems found, fixed voluntarilyMar 2026 |
| Fresenius Kabi, LLC2.5 mg per 1 mL, 25 mg per 1 mL · NDC 63323-281, 63323-272 | Fresenius Kabi USA, LLCMakes it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 |
| Gland Pharma Limited25 mg per 1 mL · NDC 68083-476 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 |
| Glenmark Pharmaceuticals Inc., USA1 mg, 2.5 mg, 5 mg, 10 mg · NDC 68462-914, 68462-338, 68462-336 +1 | Glenmark Pharmaceuticals LimitedMakes it | Dhar, India | Serious problems, FDA actionFeb 2025 |
| Pharmaceutical Associates, Inc.0.5 mg per 1 mL, 5 mg per 1 mL · NDC 0121-0654, 0121-0653 | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI PharmaMakes it | Greenville, SC, United States | No problems foundAug 2025 |
| Rising Pharma Holdings, Inc.1 mg, 2.5 mg, 5 mg, 10 mg · NDC 16571-889, 16571-892, 16571-890 +1 | Cohance Lifesciences LimitedMakes it, makes the active ingredient, tests it, packages it and labels it | Sangareddy, India | No problems foundFeb 2024 |
| Upsher-Smith Laboratories, Inc.1 mg, 2.5 mg, 5 mg, 10 mg · NDC 24979-136, 0832-6003, 24979-139 +5 | Bora Pharmaceutical Laboratories Inc. Zhongli PlantMakes it, tests it and packages it | Taoyuan City, Taiwan | Problems found, fixed voluntarilyFeb 2020 |
| Zameer Pharmaceuticals LLC1 mg, 2.5 mg, 5 mg, 10 mg · NDC 90096-121, 90096-124, 90096-122 +1 | Umedica Laboratories Private LimitedMakes it | Vapi, India | Problems found, fixed voluntarilyMar 2024 |
| Zydus Pharmaceuticals (USA) Inc.1 mg, 2.5 mg, 5 mg, 10 mg · NDC 70710-1488, 70710-1491, 70710-1489 +1 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Chartwell RX, LLC.1 mg, 2.5 mg, 5 mg, 10 mg · NDC 62135-415, 62135-419, 62135-416 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc.25 mg per 1 mL · NDC 0143-9529 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Lannett Company, Inc.1 mg, 2.5 mg, 5 mg, 10 mg · NDC 0527-1788, 0527-1791, 0527-1789 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Institutional LLC25 mg per 1 mL · NDC 67457-359 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Par Health USA, LLC25 mg per 1 mL · NDC 42023-129 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals25 mg per 1 mL · NDC 25021-838 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Fluphenazine 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:
50090-4740,50090-5758 - American Health Packaging:
60687-761,60687-749 - Atlantic Biologicals Corps.:
17856-0654 - AvPAK:
50268-366,50268-369,50268-367,50268-368 - Bryant Ranch Prepack:
72162-2635 - Carilion Materials Management:
68151-2465 - Coupler LLC:
67046-1567,67046-0975,67046-1009,67046-1547 - Golden State Medical Supply, Inc.:
51407-458,51407-461,51407-459,51407-460 - Major Pharmaceuticals:
0904-7157,0904-7160,0904-7158,0904-7159 - Marlex Pharmaceuticals, Inc.:
10135-725,10135-728,10135-726,10135-727 - Proficient Rx LP:
71205-837,71205-840,71205-838,71205-839 - Remedyrepack Inc.:
70518-4673,70518-4691,70518-4273 - TYA Pharmaceuticals:
64725-2810,64725-0272,64725-1438
Recalls
- Aug 25, 2026 · Class III · Ajanta Pharma USA Inc
Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent. - Mar 13, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA · 2 recall notices
CGMP Deviations
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.