Polyene Antifungal
Where is Nystatin made?
27 companies sell it under their own name and 22 repackagers rebottle it. Their labels name 20 factories in the United States, India, Canada and Israel.
United States 10India 8Canada 1Israel 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Cadila Healthcare Limited100000 U per 1 g, 100000 [USP'U] per 1 g · NDC 70771-1357, 70771-1585 | Zydus Lifesciences LimitedMakes it and tests it | Solan, India | No problems foundMar 2020 |
| Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | No problems foundFeb 2025 | |
| Caraco Pharmaceutical Laboratories, Ltd.100000 [USP'U] per 1 g · NDC 51672-1289 | Sun Pharma Canada Inc.Makes it | Brampton, Canada | No problems foundMar 2026 |
| Taro Pharmaceutical Industries Ltd.Makes it | Haifa Bay, Israel | No problems foundDec 2022 | |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.500000 [USP'U] · NDC 23155-051 | Strides Pharma Science LimitedMakes it, tests it and packages it | Chengalpattu, India | Problems found, fixed voluntarilyApr 2024 |
| Strides Pharma Science LimitedMakes it, tests it and packages it | Puducherry, India | Problems found, fixed voluntarilyFeb 2023 | |
| Leading Pharma, LLC100000 [USP'U] per 1 g, 100000 [USP'U] per 1 mL · NDC 69315-307, 69315-306, 69315-504 | Lyne Laboratories, Inc.Makes it | Brockton, MA, United States | Problems found, fixed voluntarilyMar 2026 |
| Medley Pharmaceuticals LimitedMakes it | Daman, India | Problems found, fixed voluntarilyMay 2023 | |
| Aurobindo Pharma Limited100000 [USP'U] per 1 g · NDC 59651-907 | Apl Healthcare LimitedMakes it and tests it | Mahabubnagar, India | No problems foundJan 2023 |
| Cosette Pharmaceuticals, Inc.100000 [USP'U] per 1 g · NDC 0713-0678, 0713-0686 | Cosette Pharmaceuticals NC Laboratories, LLCMakes it, tests it, packages it and labels it | Lincolnton, NC, United States | Problems found, fixed voluntarilyJul 2023 |
| Crown Laboratories100000 [USP'U] per 1 g · NDC 0316-0221 | Crown LaboratoriesMakes it | Johnson City, TN, United States | Problems found, fixed voluntarilySep 2025 |
| Epic Pharma, LLC100000 U per 1 g · NDC 42806-178, 42806-185, 42806-186 | Epic Pharma, LLCMakes it | Laurelton, NY, United States | Problems found, fixed voluntarilyJun 2026 |
| Genus Lifesciences Inc.100000 [USP'U] per 1 mL · NDC 64950-372 | TriRx Huntsville Pharmaceutical Services, LLCMakes it, tests it, packages it and labels it | Huntsville, AL, United States | No problems foundAug 2023 |
| Kanchan Healthcare Inc100000 U per 1 mL · NDC 85742-013 | AptaPharma Inc.Makes it | Pennsauken, NJ, United States | Problems found, fixed voluntarilyAug 2026 |
| Lupin Pharmaceuticals, Inc.100000 U per 1 g · NDC 43386-530 | Novel Laboratories, Inc.Makes it, tests it and packages it | Somerset, NJ, United States | Problems found, fixed voluntarilyApr 2026 |
| Macleods Pharmaceuticals Limited100000 1 per 1 g · NDC 33342-481, 33342-469 | Oxalis LabsMakes it, tests it, packages it and labels it | Solan, India | Problems found, fixed voluntarilyJun 2023 |
| Pharmaceutical Associates, Inc.100000 [USP'U] per 1 mL · NDC 0121-0868 | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI PharmaMakes it, tests it, packages it and labels it | Greenville, SC, United States | No problems foundAug 2025 |
| Torrent Pharma, Inc.100000 U per 1 g · NDC 13668-595, 13668-534 | Torrent Pharmaceuticals LimitedMakes it, tests it and packages it | Pithampur, India | Problems found, fixed voluntarilyOct 2019 |
| Upsher-Smith Laboratories, Inc.100000 [USP'U] per 1 g · NDC 0832-0465 | Bora Pharmaceuticals Inc.Makes it and packages it | Maple Grove, MN, United States | Problems found, fixed voluntarilyAug 2022 |
| Viona Pharmaceuticals Inc.100000 U per 1 g · NDC 72578-089 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | No problems foundFeb 2025 |
| Xttrium Laboratories, Inc.100000 [USP'U] per 1 mL · NDC 0116-4026 | Xttrium Laboratories, Inc.Makes it, packages it and labels it | Mount Prospect, IL, United States | Problems found, fixed voluntarilyJun 2026 |
| Zydus Pharmaceuticals (USA) Inc.100000 [USP'U] per 1 g · NDC 68382-370 | Zydus Lifesciences LimitedMakes it and tests it | Solan, India | No problems foundMar 2020 |
| Actavis Pharma, Inc.100000 [USP'U] per 1 g · NDC 0472-0166 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell Governmental & Specialty RX, LLC.100000 U per 1 mL · NDC 68999-813 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.100000 U per 1 mL, 500000 [USP'U] · NDC 62135-813, 62135-741 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Dr. Reddy's Laboratories Inc.100000 [USP'U] per 1 g · NDC 75907-060 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Major Pharmaceuticals100000 [USP'U] per 1 mL · NDC 0904-7276 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Northstar Rx LLC.100000 [USP'U] per 1 g · NDC 72603-491 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis Israel Pharmaceuticals Ltd100000 [USP'U] per 1 g · NDC 45802-059, 45802-048 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis US LLC100000 [USP'U] per 1 g · NDC 0574-2008 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.500000 [USP'U] · NDC 0093-0983 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Nystatin 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:
50090-5845,50090-7303,50090-2763,50090-3772+6 - Aidarex Pharmaceuticals LLC:
53217-022,33261-896 - American Health Packaging:
60687-800 - Atlantic Biologicals Corps.:
17856-0037,17856-0811,17856-1008,17856-0509+2 - AvKARE, Inc.:
42291-651 - Bryant Ranch Prepack:
63629-2516,63629-2515,72162-2007,72162-2576+15 - Cardinal Health 107, LLC:
55154-5788,55154-4314 - Carilion Materials Management:
68151-1487 - Central Texas Community Health Centers:
76413-119,76413-167 - Direct Rx:
72189-046,72189-278,72189-408 - Dispensing Solutions Inc.:
68258-3046 - H.J. Harkins Co., Inc.:
76519-1007 - Kesin Pharma Corporation:
81033-015 - Lohxa:
70166-331 - NuCare Pharmaceuticals.Inc.:
68071-2819,68071-2887,66267-952,66267-953+6 - Physicians Total Care, Inc.:
54868-0242,54868-5216,54868-1425,54868-0243 - Preferred Pharmaceuticals, Inc..:
68788-8631,68788-4099,68788-8561,68788-8690 - Proficient Rx LP:
82804-045,63187-703,71205-437,63187-847+3 - RPK Pharmaceuticals, Inc.:
53002-8220,53002-9380,53002-1805 - Rebel Distributors Corp..:
42254-303,42254-284,21695-643,42254-067+2 - RedPharm Drug. Inc.:
67296-1519,67296-1501,67296-1378,67296-1353+2 - Stat Rx USA:
16590-174
Recalls
- Jun 23, 2026 · Class II · Padagis US LLC
Subpotent Drug: Low out of specification assay results performed during long-term stability testing. - Jul 29, 2021 · Class II · PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup. - Jun 10, 2020 · Class II · Crown Laboratories · 2 recall notices
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.