Prescription drug
Where is Mirtazapine made?
14 companies sell it under their own name and 32 repackagers rebottle it. Their labels name 6 factories in India, the United States, Hungary and Bangladesh.
India 2United States 2Hungary 1Bangladesh 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Aurolife Pharma LLC7.5 mg, 15 mg, 30 mg, 45 mg · NDC 13107-031, 13107-003, 13107-032 +1 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Aurobindo Pharma LimitedMakes it | Medchal, India | Problems found, fixed voluntarilyJul 2023 | |
| Aurolife Pharma LLCMakes it | Dayton, NJ, United States | Serious problems, FDA actionDec 2021 | |
| Aurobindo Pharma Limited7.5 mg, 15 mg, 30 mg, 45 mg · NDC 65862-021, 65862-031, 65862-022 +4 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Problems found, fixed voluntarilyJul 2023 | |
| Rising Pharma Holdings, Inc.7.5 mg, 15 mg, 30 mg, 45 mg · NDC 57237-011, 57237-008, 57237-012 +4 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Problems found, fixed voluntarilyJul 2023 | |
| Camber Pharmaceuticals Inc.7.5 mg, 15 mg, 30 mg, 45 mg · NDC 31722-408, 31722-409, 31722-410 +1 | Evaric Pharmaceuticals IncMakes it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2025 |
| Caraco Pharmaceutical Laboratories, Ltd.7.5 mg, 15 mg, 30 mg, 45 mg · NDC 57664-499, 57664-500, 57664-501 +1 | ALKALOIDA Vegyeszeti Gyar zartkoruen mukodo ReszvenytarsasagMakes it | Tiszavasvari, Hungary | Problems found, fixed voluntarilyMar 2025 |
| Northstar Rx LLC.7.5 mg · NDC 72603-558 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Square Pharmaceuticals Limited15 mg, 30 mg, 45 mg · NDC 76483-110, 76483-111, 76483-112 | Square Pharmaceuticals Plc.Makes it, tests it, packages it and labels it | Gazipur, Bangladesh | Problems found, fixed voluntarilyJan 2020 |
| Viona Pharmaceuticals Inc.15 mg, 30 mg, 45 mg · NDC 72578-103, 72578-104, 72578-105 | Square Pharmaceuticals Plc.Makes it, tests it, packages it and labels it | Gazipur, Bangladesh | Problems found, fixed voluntarilyJan 2020 |
| XLCare Pharmaceuticals, Inc.7.5 mg, 15 mg, 30 mg, 45 mg · NDC 72865-369, 72865-370, 72865-371 +1 | Evaric Pharmaceuticals IncMakes it and tests it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2025 |
| ANI Pharmaceuticals, Inc.7.5 mg, 15 mg, 30 mg, 45 mg · NDC 70954-887, 70954-888, 70954-889 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Apotex Corp.15 mg, 30 mg, 45 mg · NDC 60505-0247, 60505-0248, 60505-0249 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.15 mg, 30 mg, 45 mg · NDC 0378-3515, 0378-3530, 0378-3545 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Organon LLC Remeron, Remeronsoltab15 mg, 30 mg, 45 mg · NDC 78206-160, 78206-156, 78206-161 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Prasco Laboratories7.5 mg, 15 mg, 30 mg, 45 mg · NDC 66993-607, 66993-608, 66993-609 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Mirtazapine 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:
50090-1017,50090-4222,50090-5296,50090-1019+9 - Advanced Rx Pharmacy of Tennessee, LLC:
80425-0305 - Aidarex Pharmaceuticals LLC:
33261-073,33261-074 - American Health Packaging:
68084-119,68084-120,68084-121,60687-584 - Aphena Pharma Solutions - Tennessee, Inc.:
71610-115,71610-369,43353-963,43353-535+11 - Atlantic Biologicals Corps.:
17856-0101 - AvKARE, Inc.:
42291-952,42291-494 - Bryant Ranch Prepack:
72162-1639,71335-0286,63629-2367,63629-2366+16 - Cardinal Health 107, LLC:
55154-7297,55154-0280,55154-5355,55154-8335 - Coupler Enterprises Inc.:
67046-481,67046-479,67046-482,67046-484+3 - Coupler LLC:
67046-2054,67046-1590,67046-0319,67046-0068+5 - Direct Rx:
61919-153,61919-154,72189-626,61919-155 - Golden State Medical Supply, Inc.:
51407-350,51407-351,51407-352 - H.J. Harkins Co., Inc.:
52959-902 - Major Pharmaceuticals:
0904-6519 - McKesson Packaging Services Business Unit of McKesson Corporation:
63739-098,63739-099 - Medsource Pharmaceuticals:
45865-382,45865-137,45865-361 - Mylan Institutional Inc.:
51079-086,51079-087,51079-088 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8268,0615-8269,0615-8489,0615-8663 - NuCare Pharmaceuticals.Inc.:
68071-2784,68071-2884,68071-4989,68071-2635 - Physicians Total Care, Inc.:
54868-5642,54868-4848,54868-5448,54868-4498+2 - Preferred Pharmaceuticals, Inc..:
68788-7251,68788-7324,68788-8459 - Proficient Rx LP:
71205-481,63187-206,63187-403,63187-554+1 - RPK Pharmaceuticals, Inc.:
53002-1474,53002-1270,53002-2712,53002-1712 - Rebel Distributors Corp..:
21695-081,42254-086,21695-082,42254-087+2 - RedPharm Drug. Inc.:
67296-2302 - Remedyrepack Inc.:
70518-0180,70518-2453,70518-1838,70518-1397+6 - Safecor Health, LLC:
48433-076,48433-077,48433-078 - Stat Rx USA:
16590-153,16590-154,16590-155 - State of Florida DOH Central Pharmacy:
53808-0735,53808-0384,53808-0482,53808-0646+4 - TYA Pharmaceuticals:
64725-1117,64725-0247,64725-0003 - Unit Dose Solutions, Inc.:
87441-058
Recalls
- Mar 18, 2020 · Class II · Aurobindo Pharma USA Inc.
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed - Nov 20, 2019 · Class I · AuroMedics Pharma LLC · 2 recall notices
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets. - Jan 27, 2017 · Class II · Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled - Jan 19, 2017 · Class II · Mylan Pharmaceuticals Inc.
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.