Aldosterone Antagonist
Where is Spironolactone made?
15 companies sell it under their own name and 32 repackagers rebottle it. Their labels name 11 factories in India and the United States.
India 8United States 3
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Amneal Pharmaceuticals25 mg, 25 mg per 5 mL, 50 mg, 100 mg · NDC 65162-515, 53746-515, 65162-511 +4 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyJan 2025 |
| Amneal Pharmaceuticals, LLCMakes it, tests it, packages it and labels it | Branchburg, NJ, United States | No problems foundAug 2026 | |
| Camber Pharmaceuticals Inc.25 mg, 25 mg per 5 mL, 50 mg, 100 mg · NDC 31722-096, 31722-094, 31722-691 +1 | Annora Pharma Private LimitedMakes it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Hetero Labs LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 | |
| Accord Healthcare Inc.25 mg, 50 mg, 100 mg · NDC 16729-227, 16729-225, 16729-226 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | Serious problems, FDA actionDec 2022 |
| Aurobindo Pharma Limited25 mg, 50 mg, 100 mg · NDC 59651-428, 59651-426, 59651-427 | Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Problems found, fixed voluntarilyJul 2023 |
| Cadila Healthcare Limited25 mg, 50 mg, 100 mg · NDC 70771-1029, 70771-1027, 70771-1028 | Zydus Lifesciences LimitedMakes it and tests it | Solan, India | No problems foundMar 2020 |
| Caraco Pharmaceutical Laboratories, Ltd.25 mg, 50 mg, 100 mg · NDC 53489-329, 53489-143, 53489-328 | Frontida BioPharm, LLCMakes it | Philadelphia, PA, United States | No problems foundApr 2026 |
| Jubilant Cadista Pharmaceuticals,inc.25 mg, 50 mg, 100 mg · NDC 59746-218, 59746-216, 59746-217 | Jubilant Generics LimitedMakes it | Roorkee, India | Problems found, fixed voluntarilyFeb 2024 |
| Northstar Rx LLC.25 mg, 50 mg, 100 mg · NDC 72603-136, 72603-134, 72603-135 | Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Problems found, fixed voluntarilyJul 2023 |
| Oxford Pharmaceuticals, LLC25 mg, 50 mg, 100 mg · NDC 69584-854, 69584-852, 69584-853 | Oxford Pharmaceuticals, LLCMakes it | Birmingham, AL, United States | Problems found, fixed voluntarilyNov 2023 |
| Rising Pharma Holdings, Inc.25 mg, 50 mg, 100 mg · NDC 64980-708, 64980-706, 64980-707 | Graviti Pharmaceuticals Private LimitedMakes it and tests it | Sangareddy, India | Problems found, fixed voluntarilyJul 2026 |
| Zydus Pharmaceuticals (USA) Inc.25 mg, 50 mg, 100 mg · NDC 68382-662, 68382-660, 68382-661 | Zydus Lifesciences LimitedMakes it and tests it | Solan, India | No problems foundMar 2020 |
| CMP Pharma, Inc. CaroSpir25 mg per 5 mL · NDC 46287-020 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.25 mg, 50 mg, 100 mg · NDC 0378-0437, 0378-2146, 0378-0243 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis US LLC25 mg per 5 mL · NDC 0574-1133 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Pfizer Laboratories Div Pfizer Inc Aldactone25 mg, 50 mg, 100 mg · NDC 0025-1031, 0025-1001, 0025-1041 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Spironolactone 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:
50090-6432,50090-6539,50090-3747,50090-0136+9 - Aidarex Pharmaceuticals LLC:
33261-764,53217-356,33261-869,53217-240+1 - American Health Packaging:
60687-487,60687-465,60687-476 - Aphena Pharma Solutions - Tennessee, Inc.:
71610-288,71610-102,67544-310,71610-742+3 - Asclemed USA, Inc.:
76420-558,76420-927,76420-556,76420-062+4 - Atlantic Biologicals Corps.:
17856-0120,17856-2028,17856-1133,17856-1233 - Blenheim Pharmacal, Inc.:
10544-523,10544-499 - Bryant Ranch Prepack:
72162-1627,63629-4094,71335-0304,71335-0966+30 - Cardinal Health 107, LLC:
55154-5517,55154-3556 - Carilion Materials Management:
68151-2776 - Coupler Enterprises Inc.:
67046-717 - Coupler LLC:
67046-1636,67046-1117,67046-0744,67046-0613 - Denton Pharma, Inc. DBA Northwind Pharmaceuticals.:
70934-787,70934-367,70934-256,70934-368 - Direct Rx:
72189-329,72189-495,61919-772,72189-497+1 - Dispensing Solutions Inc.:
66336-916 - Major Pharmaceuticals:
0904-6927 - Mylan Institutional Inc.:
51079-980,51079-103,51079-979 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8451,0615-8452 - Northwind Pharmaceuticals:
51655-344,51655-153,51655-636,51655-861 - NuCare Pharmaceuticals.Inc.:
68071-2968,68071-2977,68071-2962,68071-2606+9 - PD-Rx Pharmaceuticals, Inc.:
43063-835,72789-292,43063-832,72789-290+2 - PharmPak, Inc.:
54348-340 - Physicians Total Care, Inc.:
54868-5015,54868-0700,54868-4477 - Preferred Pharmaceuticals, Inc..:
68788-8381,68788-4188,68788-8545,68788-8452 - Proficient Rx LP:
71205-148,82804-977,82804-205,63187-841+9 - QPharma, Inc.:
42708-101,42708-126 - RPK Pharmaceuticals, Inc.:
53002-2806,53002-1806,53002-4720,53002-4721+3 - Rebel Distributors Corp..:
21695-766,42254-183,21695-960 - RedPharm Drug. Inc.:
67296-1403,67296-1692,67296-1100,67296-2319+1 - Remedyrepack Inc.:
70518-0665,70518-3721,70518-4512,70518-4447+6 - Safecor Health, LLC:
48433-089,48433-087,48433-088 - State of Florida DOH Central Pharmacy:
53808-0338,53808-0796,53808-0592,53808-0979
Recalls
- Aug 5, 2025 · Class II · Sun Pharmaceutical Industries Inc
Presence of foreign substance: identified as aluminum. - Jan 27, 2021 · Class I · Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets. - Jan 27, 2021 · Class II · Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets. - Sep 4, 2013 · Class II · Pfizer Us Pharmaceutical Group
Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturi…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.