Atypical Antipsychotic
Where is Paliperidone made?
17 companies sell it under their own name and 9 repackagers rebottle it. Their labels name 14 factories in India, the United States, Spain, Bangladesh, Belgium, Ireland and 1 other.
India 5United States 3Spain 2Bangladesh 1Belgium 1Ireland 1China 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Janssen Pharmaceuticals, Inc. Invega, Invega Hafyera, Invega Sustenna, Invega Trinza1.5 mg, 3 mg, 6 mg, 9 mg, 39 mg per 0.25 mL, 78 mg per 0.5 mL · NDC 50458-554, 50458-611, 50458-562 +12 | Janssen Pharmaceutica NVMakes it, tests it and packages it | Beerse, Belgium | Problems found, fixed voluntarilySep 2025 |
| Janssen Pharmaceutical Sciences Unlimited CompanyMakes the active ingredient | Co Cork, Ireland | Problems found, fixed voluntarilyOct 2023 | |
| Janssen-Cilag Manufacturing, LLCMakes it and tests it | Gurabo, PR, United States | Problems found, fixed voluntarilyFeb 2026 | |
| Shandong Luye Pharmaceutical Co., Ltd. Erzofri extended-release39 mg per 0.25 mL, 78 mg per 0.5 mL, 117 mg per 0.75 mL, 156 mg per 1 mL, 234 mg per 1.5 mL, 351 mg per 2.25 mL · NDC 72526-107, 72526-108, 72526-109 +3 | Curia Spain SauMakes the active ingredient, tests it and mills it | Boecillo, Spain | Problems found, fixed voluntarilyFeb 2023 |
| Interquim, S.A.Makes the active ingredient | Sant Cugat del Valles (BA), Spain | Problems found, fixed voluntarilySep 2024 | |
| Shandong Luye Pharmaceutical Co., LTD.Makes it, tests it, packages it and labels it | Yantai, China | No problems foundMay 2024 | |
| ANI Pharmaceuticals, Inc.1.5 mg, 3 mg, 6 mg, 9 mg · NDC 43975-349, 43975-350, 43975-351 +1 | Inventia Healthcare LimitedMakes it and tests it | Thane, India | Problems found, fixed voluntarilyFeb 2025 |
| Ajanta Pharma USA Inc.1.5 mg, 3 mg, 6 mg, 9 mg · NDC 27241-276, 27241-277, 27241-278 +1 | Ajanta Pharma LimitedMakes it | Bharuch, India | No problems foundJun 2023 |
| Alembic Pharmaceuticals Inc.1.5 mg, 3 mg, 6 mg, 9 mg · NDC 62332-803, 62332-804, 62332-805 +1 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited1.5 mg, 3 mg, 6 mg, 9 mg · NDC 46708-803, 46708-804, 46708-805 +1 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Amneal Pharmaceuticals1.5 mg, 3 mg, 6 mg, 9 mg · NDC 65162-280, 65162-281, 65162-282 +1 | Amneal Pharmaceuticals of New York, LLCMakes it, tests it, packages it and labels it | Brookhaven, NY, United States | No problems foundSep 2026 |
| Archis Pharma LLC3 mg, 6 mg, 9 mg · NDC 72819-158, 72819-159, 72819-160 | Mylan Laboratories LimitedMakes it | Nashik, India | Serious problems, FDA actionMay 2026 |
| Ascent Pharmaceuticals, Inc.1.5 mg, 3 mg, 6 mg, 9 mg · NDC 43602-294, 43602-295, 43602-296 +1 | Ascent Pharmaceuticals IncMakes it, tests it and packages it | Central Islip, NY, United States | Problems found, fixed voluntarilyAug 2024 |
| Camber Pharmaceuticals Inc.1.5 mg, 3 mg, 6 mg, 9 mg · NDC 31722-317, 31722-318, 31722-319 +1 | Ascent Pharmaceuticals IncMakes it, tests it and packages it | Central Islip, NY, United States | Problems found, fixed voluntarilyAug 2024 |
| Caraco Pharmaceutical Laboratories, Ltd.1.5 mg, 3 mg, 6 mg, 9 mg · NDC 47335-744, 47335-765, 47335-766 +1 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Dadra, India | Problems found, fixed voluntarilyMar 2019 |
| Eskayef Pharmaceuticals Limited1.5 mg, 3 mg, 6 mg, 9 mg · NDC 72658-1253, 72658-1254, 72658-1255 +1 | Eskayef Pharmaceuticals LimitedMakes it | Gazipur, Bangladesh | Not inspected on record |
| Inventia Healthcare Private Limited1.5 mg, 3 mg, 6 mg, 9 mg · NDC 49252-032, 49252-033, 49252-034 +1 | Inventia Healthcare LimitedMakes it | Thane, India | Problems found, fixed voluntarilyFeb 2025 |
| Northstar Rx LLC.1.5 mg, 3 mg, 6 mg, 9 mg · NDC 16714-866, 16714-867, 16714-868 +1 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Dadra, India | Problems found, fixed voluntarilyMar 2019 |
| Westminster Pharmaceuticals, LLC1.5 mg, 3 mg, 6 mg, 9 mg · NDC 69367-432, 69367-433, 69367-434 +1 | Eskayef Pharmaceuticals LimitedMakes it and tests it | Gazipur, Bangladesh | Not inspected on record |
| TOLMAR Inc.39 mg per 0.25 mL, 78 mg per 0.5 mL, 117 mg per 0.75 mL, 156 mg per 1 mL, 234 mg per 1.5 mL · NDC 63646-713, 63646-710, 63646-714 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Tris Pharma Inc1.5 mg, 3 mg, 6 mg, 9 mg · NDC 27808-222, 27808-223, 27808-224 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Paliperidone 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.
- American Health Packaging:
60687-459,60687-470 - AvKARE, Inc.:
42291-915,42291-916,42291-917,42291-918 - Bryant Ranch Prepack:
72162-2648,72162-2649,72162-2650,72162-2651 - Carilion Materials Management:
68151-5041 - Coupler LLC:
67046-1539,67046-1630 - Major Pharmaceuticals:
0904-6935,0904-6936,0904-6937 - Rebel Distributors Corp..:
21695-455 - Remedyrepack Inc.:
70518-4269,70518-4268,70518-4267 - TYA Pharmaceuticals:
64725-0550
Recalls
- Feb 28, 2022 · Class II · The Harvard Drug Group
Failed Dissolution Specifications
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.