Nitrofuran Antibacterial
Where is Nitrofurantoin made?
26 companies sell it under their own name and 32 repackagers rebottle it. Their labels name 21 factories in India and the United States.
India 13United States 8
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Amneal Pharmaceuticals25 mg / 75 mg, 25 mg per 5 mL, 50 mg, 100 mg · NDC 0115-2024, 0115-1645, 65162-478 +4 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | No problems foundJul 2024 |
| Amneal Pharmaceuticals, LLCMakes it, tests it, packages it and labels it | Branchburg, NJ, United States | No problems foundAug 2026 | |
| Amneal Pharmaceuticals, LLCMakes it, tests it, packages it and labels it | Piscataway, NJ, United States | No problems foundApr 2026 | |
| Aurobindo Pharma Limited25 mg, 25 mg / 75 mg, 25 mg per 5 mL, 50 mg, 100 mg · NDC 59651-795, 59651-942, 65862-929 +2 | 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 | |
| BluePoint Laboratories.25 mg, 25 mg / 75 mg, 50 mg, 100 mg · NDC 68001-386, 68001-605, 68001-384 +4 | Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 |
| Sidmak Laboratories (India) Private LimitedMakes it | Dehradun, India | No problems foundMay 2023 | |
| Northstar Rx LLC.25 mg, 25 mg / 75 mg, 25 mg per 5 mL, 50 mg, 100 mg · NDC 72603-184, 72603-182, 72603-196 +3 | Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 |
| Novitium Pharma LLCMakes it, tests it, packages it and labels it | East Windsor, NJ, United States | No problems foundFeb 2024 | |
| ANI Pharmaceuticals, Inc.25 mg per 5 mL · NDC 70954-496 | Novitium Pharma LLCMakes it, tests it, packages it and labels it | East Windsor, NJ, United States | No problems foundFeb 2024 |
| Alembic Pharmaceuticals Inc.25 mg, 50 mg, 100 mg · NDC 62332-391, 62332-389, 62332-390 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited25 mg, 50 mg, 100 mg · NDC 46708-391, 46708-389, 46708-390 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Almatica Pharma Inc. Macrodantin, Macrobid25 mg, 25 mg / 75 mg, 50 mg, 100 mg · NDC 52427-288, 52427-286, 52427-285 +1 | Norwich Pharmaceuticals, Inc.Makes it, tests it and packages it | Norwich, NY, United States | No problems foundMay 2026 |
| Alvogen Inc. nitrofurantoin macrocrystals, Nitrofurantoin Monohydrate/ Macrocrystalline25 mg, 25 mg / 75 mg, 50 mg, 100 mg · NDC 47781-308, 47781-306, 47781-303 +1 | Norwich Pharmaceuticals, Inc.Makes it, tests it and packages it | Norwich, NY, United States | No problems foundMay 2026 |
| Biocon Pharma Inc.25 mg per 5 mL · NDC 70377-118 | Carnegie Pharmaceuticals, LLCMakes it | Delran, NJ, United States | No problems foundOct 2025 |
| Cadila Healthcare Limited50 mg, 100 mg · NDC 70771-1171, 70771-1170 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Camber Pharmaceuticals Inc.25 mg per 5 mL · NDC 31722-491 | Annora Pharma Private LimitedMakes it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Caraco Pharmaceutical Laboratories, Ltd.25 mg, 50 mg, 100 mg · NDC 57664-233, 57664-231, 57664-232 | Sidmak Laboratories (India) Private LimitedMakes it | Dehradun, India | No problems foundMay 2023 |
| Creekwood Pharmaceuticals LLC25 mg / 75 mg · NDC 82619-147 | V-Ensure Pharma Technologies Pvt LimitedMakes it, tests it, packages it and labels it | Raigad, India | Problems found, fixed voluntarilyMay 2024 |
| H.J. Harkins Co., Inc. Nitrofurantoin Monohydrate Macrocrystalline25 mg / 75 mg · NDC 52959-783 | H.J. Harkins Company, Inc.Makes it, repackages it and relabels it | Grover Beach, California, United States | Problems found, fixed voluntarilyMar 2023 |
| Jubilant Cadista Pharmaceuticals Inc.25 mg / 75 mg · NDC 59746-762 | Inventia Healthcare LimitedMakes it | Thane, India | Problems found, fixed voluntarilyFeb 2025 |
| Lifestar Pharma LLC.25 mg, 25 mg / 75 mg, 50 mg, 100 mg · NDC 70756-412, 70756-410, 70756-404 +1 | Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 |
| Lupin Pharmaceuticals, Inc.25 mg per 5 mL, 50 mg, 100 mg · NDC 43386-642, 43386-450, 43386-641 | Novel Laboratories, Inc.Makes it, tests it and packages it | Somerset, NJ, United States | Problems found, fixed voluntarilyApr 2026 |
| Micro Labs Limited100 mg · NDC 42571-393 | Micro Labs LimitedMakes it, tests it, packages it and labels it | Verna, India | Problems found, fixed voluntarilyMay 2025 |
| Nostrum Laboratories, Inc.25 mg per 5 mL · NDC 70408-239 | Nostrum Laboratories, Inc.Makes it, tests it and packages it | Bryan, Ohio, United States | Problems found, fixed voluntarilyMar 2025 |
| Novel Laboratories, Inc.25 mg per 5 mL, 50 mg, 100 mg · NDC 40032-642, 40032-450, 40032-641 | Novel Laboratories, Inc.Makes it, tests it and packages it | Somerset, NJ, United States | Problems found, fixed voluntarilyApr 2026 |
| Rising Pharma Holdings, Inc.25 mg per 5 mL, 50 mg per 5 mL · NDC 16571-740, 64980-593, 16571-888 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Somerset Therapeutics, LLC25 mg per 5 mL · NDC 70069-829 | Cohance Lifesciences LimitedMakes it, tests it and packages it | Sangareddy, India | No problems foundFeb 2024 |
| Zydus Pharmaceuticals (USA) Inc.50 mg, 100 mg · NDC 68382-560, 68382-559 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Sandoz Inc.25 mg / 75 mg · NDC 0185-0122 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Trigen Laboratories, LLC25 mg / 75 mg · NDC 13811-719 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Nitrofurantoin 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:
50090-0314,50090-5693,50090-7217,50090-7308+6 - Aidarex Pharmaceuticals LLC:
33261-226,33261-160 - American Health Packaging:
60687-850,60687-839 - Apotheca, Inc.:
12634-415 - Asclemed USA, Inc.:
76420-195,76420-884 - AvPAK:
50268-624,50268-623 - Blenheim Pharmacal, Inc.:
10544-601,10544-086 - Bryant Ranch Prepack:
71335-2212,71335-1135,71335-1069,71335-0024+9 - Central Texas Community Health Centers:
76413-144,76413-113,76413-115,76413-165 - Clinical Solutions Wholesale:
58118-0303 - Coupler LLC:
67046-1271,67046-1198 - Direct Rx:
61919-458,61919-842,61919-021,72189-395+2 - Liberty Pharmaceuticals, Inc.:
0440-1866 - Major Pharmaceuticals:
0904-7571,0904-7026 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8531 - Northwind Pharmaceuticals:
82868-015,82868-021,51655-611,82868-065+1 - NuCare Pharmaceuticals.Inc.:
68071-2647,68071-3460,68071-2363,68071-2550+7 - PD-Rx Pharmaceuticals, Inc.:
72789-270,72789-340,72789-387,72789-386+2 - PharmPak, Inc.:
54348-849 - Physicians Total Care, Inc.:
54868-0473,54868-6203,54868-0107 - Preferred Pharmaceuticals, Inc..:
68788-8571,68788-8258 - Proficient Rx LP:
71205-297,71205-171,63187-245,82804-131+6 - QPharma, Inc.:
42708-184,42708-178 - RPK Pharmaceuticals, Inc.:
53002-7041,53002-7042,53002-7040 - Rebel Distributors Corp..:
42254-070,21695-300,42254-064 - RedPharm Drug Inc.:
67296-0658,67296-0528 - RedPharm Drug. Inc.:
67296-2150,67296-2251,67296-2353,67296-1640+4 - Remedyrepack Inc.:
70518-4244,70518-3827,70518-0265,70518-3717+4 - St. Mary's Medical Park Pharmacy:
60760-194,60760-853,60760-848 - Stat Rx USA:
16590-380 - Unit Dose Services:
50436-0308,50436-6590 - Verityrx, LLC:
83939-0016
Recalls
- Jul 9, 2024 · Class II · Sun Pharmaceutical Industries Inc
Failed Dissolution Specifications - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - Jul 24, 2019 · Class II · Alvogen, Inc · 2 recall notices
Failed dissolution specifications - Dec 21, 2018 · Class II · Lupin Somerset
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay. - Nov 7, 2018 · Class III · RemedyRepack Inc.
Cross contamination with other products: Product is being recalled due to the potential presence of unrelated ingredients (Benazepril, Haloperidol and Perphenazine). - Nov 2, 2018 · Class III · Sandoz Inc · 2 recall notices
Cross Contamination with Other Products - Jun 28, 2018 · Class II · Lupin Somerset
Subpotent Drug and Failed Content Uniformity. - Apr 21, 2015 · Class II · Alvogen, Inc
Failed Dissolution Specification; 6 month time point
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.