Dihydrofolate Reductase Inhibitor Antibacterial, Sulfonamide Antimicrobial
Where is Sulfamethoxazole and Trimethoprim made?
17 companies sell it under their own name and 52 repackagers rebottle it. Their labels name 14 factories in India, the United States and Hungary.
India 8United States 5Hungary 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Aurobindo Pharma Limited40 mg per 5 mL / 200 mg per 5 mL, 80 mg / 400 mg, 160 mg / 800 mg · NDC 65862-420, 65862-496, 65862-419 | Apl Healthcare LimitedMakes it and tests it | Mahabubnagar, India | No problems foundJan 2023 |
| 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 | |
| Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 | |
| Rising Pharma Holdings, Inc.80 mg / 400 mg, 160 mg / 800 mg · NDC 57237-233, 57237-232 | Apl Healthcare LimitedMakes it and tests it | Mahabubnagar, India | No problems foundJan 2023 |
| Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Problems found, fixed voluntarilyJul 2023 | |
| Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 | |
| Caraco Pharmaceutical Laboratories, Ltd. Bactrim DS, Bactrim80 mg / 400 mg, 160 mg / 800 mg · NDC 49708-146, 53489-146, 49708-145 +1 | ALKALOIDA Vegyeszeti Gyar zartkoruen mukodo ReszvenytarsasagMakes it, tests it and packages it | Tiszavasvari, Hungary | Problems found, fixed voluntarilyMar 2025 |
| Frontida BioPharm, LLCMakes it, tests it and packages it | Philadelphia, PA, United States | No problems foundApr 2026 | |
| Cronus Pharma LLC80 mg / 400 mg, 160 mg / 800 mg · NDC 69043-011, 69043-010 | Apl Healthcare LimitedMakes it and tests it | Mahabubnagar, India | No problems foundJan 2023 |
| Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 | |
| ANI Pharmaceuticals, Inc.40 mg per 5 mL / 200 mg per 5 mL · NDC 70954-258 | Novitium Pharma LLCMakes it, tests it, packages it and labels it | East Windsor, NJ, United States | No problems foundFeb 2024 |
| Akorn40 mg per 5 mL / 200 mg per 5 mL · NDC 50383-823, 50383-824 | AkornMakes it and packages it | Location not on file | Not inspected on record |
| Amneal Pharmaceuticals80 mg / 400 mg, 160 mg / 800 mg · NDC 53746-272, 65162-272, 53746-271 +1 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | No problems foundJul 2024 |
| Chartwell RX, LLC.40 mg per 5 mL / 200 mg per 5 mL, 80 mg / 400 mg, 160 mg / 800 mg, 160 mg per 20 mL / 800 mg per 20 mL · NDC 62135-898, 62135-873, 62135-749 +1 | Chartwell Pharmaceuticals Congers, LLC.Makes it | Congers, NY, United States | Serious problems, FDA actionNov 2025 |
| Lupin Pharmaceuticals, Inc.40 mg per 5 mL / 200 mg per 5 mL · NDC 70748-134 | Lupin LimitedMakes it and packages it | Chhatrapati Sambhajinagar, India | Problems found, fixed voluntarilyMar 2024 |
| New Horizon Rx Group, LLC160 mg / 800 mg · NDC 58517-140 | Amneal Pharmaceuticals of New York, LLCMakes it | Hauppauge, NY, United States | No problems foundFeb 2020 |
| Pharmaceutical Associates, Inc. Sulfatrim40 mg per 5 mL / 200 mg per 5 mL · NDC 0121-0853, 0121-0854 | TriRx Huntsville Pharmaceutical Services, LLCMakes it, packages it and labels it | Huntsville, AL, United States | No problems foundAug 2023 |
| Somerset Therapeutics, LLC16 mg per 1 mL / 80 mg per 1 mL · NDC 70069-361, 70069-362, 70069-363 | Somerset Therapeutics Private LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Serious problems, FDA actionFeb 2025 |
| Vista Pharmaceuticals, Inc.80 mg / 400 mg, 160 mg / 800 mg · NDC 61971-120, 61971-115 | Vista Pharmaceuticals LimitedMakes it, tests it and packages it | Nalgonda, India | Serious problems, FDA actionFeb 2018 |
| Chartwell Governmental & Specialty RX, LLC.160 mg per 20 mL / 800 mg per 20 mL · NDC 68999-873 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Institutional LLC16 mg per 1 mL / 80 mg per 1 mL · NDC 67457-778, 67457-779 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Prasco Laboratories40 mg per 5 mL / 200 mg per 5 mL · NDC 66993-727 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Parenteral Medicines, Inc.16 mg per 1 mL / 80 mg per 1 mL · NDC 0703-9503, 0703-9514, 0703-9526 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Sulfamethoxazole and Trimethoprim 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:
50090-3973,50090-4852,50090-4430,50090-2479+20 - Advanced Rx Pharmacy of Tennessee, LLC:
80425-0003,80425-0002,80425-0001 - Aidarex Pharmaceuticals LLC:
33261-148,33261-396 - American Health Packaging:
60687-614,60687-442,60687-603 - Aphena Pharma Solutions - Tennessee, Inc.:
43353-368 - Apotheca, Inc.:
12634-177,12634-779 - Asclemed USA, Inc.:
76420-064 - Atlantic Biologicals Corps.:
17856-0007,17856-0823,17856-5181,17856-0496 - AvKARE, Inc.:
42291-759,42291-758 - AvPAK:
50268-729,50268-728 - Blenheim Pharmacal, Inc.:
10544-092,10544-053,10544-926,10544-525+1 - Bryant Ranch Prepack:
63629-1765,71335-0762 - Cardinal Health 107, LLC:
55154-2580,55154-7895 - Central Texas Community Health Centers:
76413-125,76413-135,76413-151 - Coupler Enterprises Inc.:
67046-715,67046-714,67046-716 - Coupler LLC:
67046-1070,67046-0295 - Denton Pharma, Inc. DBA Northwind Pharmaceuticals.:
70934-043,70934-544 - Department of State Health Services, Pharmacy Branch:
55695-008 - Direct Rx:
61919-766,61919-210,61919-144,61919-645 - Golden State Medical Supply, Inc.:
60429-259,60429-258 - H.J. Harkins Co., Inc.:
52959-144,52959-766 - Keltman Pharmaceuticals Inc.:
68387-385 - Kesin Pharma Corporation:
81033-012 - Lake Erie Medical DBA Quality Care Products LLC:
55700-611 - Liberty Pharmaceuticals, Inc.:
0440-2406 - Life Line Home Care Services, Inc.:
75921-578 - Major Pharmaceuticals:
0904-2725 - MedVantx, Inc.:
66116-369 - Medsource Pharmaceuticals:
45865-475 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8121 - Northwind Pharmaceuticals:
82868-092,51655-307,51655-188 - NuCare Pharmaceuticals.Inc.:
66267-196,66267-816,68071-4948,68071-4710+1 - PD-Rx Pharmaceuticals, Inc.:
72789-018,72789-064 - PharmPak, Inc.:
54348-625 - Pharmasource Meds, LLC:
82982-044 - Physicians Total Care, Inc.:
54868-0337,54868-0021,54868-0276,54868-4711 - Preferred Pharmaceuticals, Inc..:
68788-7622,68788-8607,68788-7345 - Proficient Rx LP:
63187-782,63187-695,63187-008,71205-810 - QPharma, Inc.:
42708-053 - RPK Pharmaceuticals, Inc.:
53002-2101,53002-2100 - ReadyMeds:
64205-272 - Rebel Distributors Corp..:
21695-125,21695-701 - RedPharm Drug. Inc.:
67296-0227,67296-0387,67296-0724,67296-1904+10 - Remedyrepack Inc.:
70518-3432,70518-0863,70518-2604,70518-3454 - Sportpharm LLC:
85766-015 - St. Mary's Medical Park Pharmacy:
60760-541 - Stat Rx USA:
16590-210 - State of Florida DOH Central Pharmacy:
53808-0914,53808-0798,53808-0981 - TYA Pharmaceuticals:
64725-0146 - Unit Dose Services:
50436-4693,50436-4694 - Unit Dose Solutions, Inc.:
87441-078 - Verityrx, LLC:
83939-0023
Recalls
- Sep 2, 2025 · Class II · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · 2 recall notices
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets. - Aug 20, 2025 · Class II · Northwind Pharmaceuticals LLC
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets. - Aug 18, 2025 · Class II · Amneal Pharmaceuticals, LLC
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. - Jun 2, 2025 · Class I · Amneal Pharmaceuticals, LLC
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination. - Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse - Jul 7, 2021 · Class II · Aurobindo Pharma USA Inc.
Presence of Foreign Substance- Potential of metal contamination. - Aug 10, 2020 · Class II · Aurobindo Pharma USA Inc.
Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s). - Apr 19, 2018 · Class II · Sun Pharmaceutical Industries, Inc.
Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign matter identified as polyethylene was detected in two (2) tablets. - Mar 13, 2017 · Class II · Akorn Inc
Failed Dissolution Specifications - Sep 27, 2011 · Class II · Shamrock Medical Solutions Group LLC
Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.