Calcineurin Inhibitor Immunosuppressant
Where is Tacrolimus made?
27 companies sell it under their own name and 14 repackagers rebottle it. Their labels name 16 factories in India, Ireland, the United States, Japan, China and Germany.
India 10Ireland 2United States 1Japan 1China 1Germany 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Astellas Pharma US, Inc. Prograf, Astagraf XL0.2 mg, 0.5 mg, 1 mg, 5 mg, 5 mg per 1 mL · NDC 0469-1230, 0469-0607, 0469-0647 +6 | Astellas Ireland Co., Ltd.Makes it and tests it | Killorglin, Ireland | Problems found, fixed voluntarilySep 2022 |
| Astellas Pharma Inc.Makes it, makes the active ingredient and tests it | Toyama, Japan | No problems foundApr 2024 | |
| Biocon Pharma Inc.0.5 mg, 1 mg, 5 mg · NDC 70377-014, 70377-015, 70377-016 | Biocon LimitedMakes the active ingredient | Bengaluru, India | Problems found, fixed voluntarilySep 2024 |
| Biocon Pharma LimitedMakes it | Bengaluru, India | No problems foundJun 2023 | |
| Accord Healthcare Inc.0.3 mg per 1 g, 0.5 mg, 1 mg, 1 mg per 1 g, 5 mg · NDC 16729-421, 16729-041, 16729-042 +2 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | No problems foundJul 2024 |
| Ajenat Pharmaceuticals LLC0.5 mg, 1 mg, 5 mg · NDC 82983-400, 82983-401, 82983-402 | Ajenat Pharmaceuticals LLCMakes it and tests it | Largo, FL, United States | No problems foundFeb 2025 |
| Ascend Laboratories, LLC0.5 mg, 1 mg, 5 mg · NDC 67877-278, 67877-279, 67877-280 | Alkem Laboratories LimitedMakes it | Baddi Solan, India | Problems found, fixed voluntarilyMar 2024 |
| BPI Labs, LLC0.5 mg, 1 mg, 5 mg · NDC 54288-134, 54288-135, 54288-133 | Ajenat Pharmaceuticals LLCMakes it and tests it | Largo, FL, United States | No problems foundFeb 2025 |
| Chengdu Suncadia Medicine Co., Ltd.0.5 mg, 1 mg, 5 mg · NDC 71432-2001, 71432-2002, 71432-2003 | Chengdu Suncadia Medicine Co., Ltd.Makes it | Chengdu, China | Not inspected on record |
| Concord Biotech Limited0.5 mg, 1 mg, 5 mg · NDC 68254-5004, 68254-5005, 68254-5006 | Concord Biotech LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Dr.Reddy's Laboratories Ltd.0.5 mg, 1 mg, 5 mg · NDC 55111-525, 55111-526, 55111-527 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Medchal-Malkajgiri, India | Problems found, fixed voluntarilyOct 2023 |
| Encube Ethicals, Inc.1 mg per 1 g · NDC 21922-011 | Encube Ethicals LimitedMakes it, tests it, packages it and labels it | Ponda, India | Problems found, fixed voluntarilyJun 2024 |
| Glenmark Pharmaceuticals Inc., USA0.3 mg per 1 g, 0.5 mg, 1 mg, 1 mg per 1 g, 5 mg · NDC 68462-881, 68462-685, 68462-686 +2 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Dhar, India | Serious problems, FDA actionFeb 2025 |
| Jubilant Cadista Pharmaceuticals Inc.0.5 mg, 1 mg, 5 mg · NDC 59746-798, 59746-799, 59746-800 | Panacea Biotec Pharma LimitedMakes it | Solan, India | Serious problems, FDA actionOct 2023 |
| Northstar Rx LLC.0.5 mg, 1 mg, 5 mg · NDC 16714-098, 16714-099, 16714-100 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Dhar, India | Serious problems, FDA actionFeb 2025 |
| Padagis Israel Pharmaceuticals Ltd0.3 mg per 1 g, 1 mg per 1 g · NDC 45802-390, 45802-700 | LEO Laboratories Ltd.Makes it, tests it, packages it and labels it | Dublin, Ireland | Problems found, fixed voluntarilyJan 2026 |
| Panacea Biotec Limited0.5 mg, 1 mg, 5 mg · NDC 43817-421, 43817-422, 43817-423 | Panacea Biotec Pharma LimitedMakes it | Solan, India | Serious problems, FDA actionOct 2023 |
| Quallent Pharmaceuticals Health LLC0.5 mg, 1 mg, 5 mg · NDC 82009-164, 82009-054, 82009-165 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Medchal-Malkajgiri, India | Problems found, fixed voluntarilyOct 2023 |
| Sincerus Florida, LLC0.1 g per 100 g · NDC 72934-2174, 72934-4173 | Sincerus Florida, LLCMakes it | Location not on file | Not inspected on record |
| Stellon Biotech Inc.0.5 mg, 1 mg, 5 mg · NDC 85972-101, 85972-102, 85972-103 | Concord Biotech LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Strides Pharma Science Limited0.5 mg, 1 mg, 5 mg · NDC 64380-720, 64380-721, 64380-722 | Strides Pharma Science LimitedMakes it, tests it and packages it | Bengaluru, India | Problems found, fixed voluntarilyMay 2026 |
| Veloxis Pharmaceuticals, Inc EnvarsusXR0.75 mg, 1 mg, 4 mg · NDC 68992-3075, 68992-3010, 68992-3040 | Rottendorf Pharma GmbHMakes it, tests it, packages it and labels it | Ennigerloh, Germany | Problems found, fixed voluntarilyMar 2024 |
| Amneal Pharmaceuticals0.5 mg, 1 mg, 5 mg · NDC 69238-2780, 69238-2781, 69238-2782 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Belcher Pharmaceuticals,LLC0.5 mg, 1 mg, 5 mg · NDC 62250-665, 62250-666, 62250-667 | The label doesn't name the factory. Plants this company names for other drugs | ||
| E. FOUGERA & CO., A division of Nycomed US Inc.0.3 mg per 1 g, 1 mg per 1 g · NDC 0168-0417, 0168-0416 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.0.5 mg, 1 mg, 5 mg · NDC 0378-2045, 0378-2046, 0378-2047 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Nexus Pharamaceuticals Inc.5 mg per 1 mL · NDC 14789-135 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Pella Pharmaceuticals Co. ltd30 mg per 30 g · NDC 82160-124 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc.0.5 mg, 1 mg, 5 mg · NDC 0781-2102, 0781-2103, 0781-2104 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Tacrolimus 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:
50090-5596,50090-5581 - American Health Packaging:
68084-449,68084-450,68084-451 - Aphena Pharma Solutions - Tennessee, Inc.:
43353-178,43353-317 - AvPAK:
50268-736,50268-737 - Bryant Ranch Prepack:
63629-9581,63629-8725,71335-2189,63629-8723+2 - Cardinal Health 107, LLC:
55154-4080,55154-4168 - Direct Rx:
72189-536 - Golden State Medical Supply, Inc.:
60429-377,60429-378,60429-379 - Major Pharmaceuticals:
0904-6623,0904-7097,0904-6624 - Mylan Institutional Inc.:
51079-817,51079-818,51079-028 - Physicians Total Care, Inc.:
54868-5233 - Proficient Rx LP:
82804-032 - Rebel Distributors Corp..:
21695-170 - Safecor Health, LLC:
48433-092,48433-093,48433-094
Recalls
- Dec 23, 2024 · Class I · Astellas Pharma US Inc. · 2 recall notices
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules - Dec 15, 2023 · Class II · Dr. Reddy's Laboratories, Inc.
Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules. - Feb 8, 2023 · Class II · Dr. Reddy's Laboratories, Inc.
Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules. - Jul 11, 2022 · Class III · Glenmark Pharmaceuticals Inc., USA
Defective Container: Tube split from side seam - Dec 22, 2020 · Class III · Strides Pharma Inc.
Failed Moisture Limits - Mar 23, 2020 · Class III · Mylan Pharmaceuticals Inc.
Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles. - Oct 22, 2013 · Class II · Sandoz Incorporated
Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin - Jun 29, 2012 · Class II · Mylan LLC.
Failed USP Content Uniformity Requirements: OOS result reported on retained samples.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.