Arteriolar Vasodilator
Where is Hydralazine made?
22 companies sell it under their own name and 26 repackagers rebottle it. Their labels name 16 factories in India, the United States and China.
India 10United States 5China 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Camber Pharmaceuticals Inc.10 mg, 25 mg, 50 mg, 100 mg · NDC 31722-519, 31722-522, 31722-520 +1 | Annora Pharma Private LimitedMakes it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Hetero Labs LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 | |
| Hetero Labs LimitedMakes it | Hobli Vemagal Kolar, India | No problems foundJan 2025 | |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.10 mg, 25 mg, 50 mg, 100 mg · NDC 23155-832, 23155-835, 23155-833 +1 | Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.Makes it, tests it and packages it | East Brunswick, NJ, United States | No problems foundSep 2023 |
| Stallion Laboratories Private LimitedMakes it, tests it and packages it | Ahmedabad, India | Problems found, fixed voluntarilyJul 2024 | |
| Akorn20 mg per 1 mL · NDC 17478-934 | AkornMakes it, tests it and sterilizes it | Location not on file | Not inspected on record |
| American Regent, Inc.20 mg per 1 mL · NDC 0517-0901 | American Regent, Inc.Makes it, tests it and sterilizes it | Shirley, NY, United States | Problems found, fixed voluntarilyApr 2024 |
| Ascend Laboratories, LLC10 mg, 25 mg, 50 mg, 100 mg · NDC 67877-293, 67877-290, 67877-292 +1 | Alkem Laboratories LimitedMakes it | Amaliya Daman, India | No problems foundAug 2019 |
| AuroMedics Pharma LLC20 mg per 1 mL · NDC 55150-400 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| Baxter Healthcare Corporation20 mg per 1 mL · NDC 43066-041 | Immacule Lifesciences Private LimitedMakes it, tests it, packages it, labels it and sterilizes it | Solan, India | Serious problems, FDA actionSep 2025 |
| Cadila Pharmaceuticals Limited25 mg, 50 mg, 100 mg · NDC 71209-018, 71209-016, 71209-017 | Cadila Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | No problems foundSep 2025 |
| Civica, Inc.20 mg per 1 mL · NDC 72572-265 | American Regent, Inc.Makes it and tests it | Shirley, NY, United States | Problems found, fixed voluntarilyApr 2024 |
| Exelan Pharmaceuticals, Inc.10 mg, 25 mg, 50 mg, 100 mg · NDC 76282-309, 76282-312, 76282-310 +1 | InvaGen Pharmaceuticals, IncMakes it and tests it | Hauppauge, NY, United States | No problems foundOct 2023 |
| Fresenius Kabi, LLC20 mg per 1 mL · NDC 63323-614 | Fresenius Kabi USA, LLCMakes it and tests it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 |
| Macleods Pharmaceuticals Limited10 mg, 25 mg, 50 mg, 100 mg · NDC 33342-374, 33342-377, 33342-375 +1 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | District Solan, India | Problems found, fixed voluntarilyOct 2023 |
| Meitheal Pharmaceuticals Inc.20 mg per 1 mL · NDC 71288-205 | Kindos Pharmaceuticals Co., Ltd.Makes it | Chengdu, China | Problems found, fixed voluntarilyJul 2024 |
| Modavar Pharmaceuticals LLC25 mg, 50 mg, 100 mg · NDC 72241-006, 72241-004, 72241-005 | Cadila Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | No problems foundSep 2025 |
| Radha Pharmaceuticals, Inc.10 mg, 25 mg, 50 mg, 100 mg · NDC 77771-182, 77771-185, 77771-183 +1 | ScieGen Pharmaceuticals, INC.Makes it and tests it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 |
| ScieGen Pharmaceuticals, Inc.10 mg, 25 mg, 50 mg, 100 mg · NDC 50228-182, 50228-185, 50228-183 +1 | ScieGen Pharmaceuticals, INC.Makes it and tests it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 |
| Strides Pharma Science Limited10 mg, 25 mg, 50 mg, 100 mg · NDC 64380-733, 64380-736, 64380-734 +1 | Strides Pharma Science LimitedMakes it, tests it and packages it | Bengaluru, India | Problems found, fixed voluntarilyMay 2026 |
| Chartwell RX, LLC.10 mg, 25 mg, 50 mg, 100 mg · NDC 62135-579, 62135-582, 62135-580 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc.20 mg per 1 mL · NDC 0641-6231 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Navinta LLC20 mg per 1 mL · NDC 68475-514 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.10 mg, 25 mg, 50 mg, 100 mg · NDC 50111-398, 50111-397, 50111-327 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Zydus Pharmaceuticals (USA) Inc.20 mg per 1 mL · NDC 70710-1988 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Hydralazine 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:
50090-4518,50090-0138,50090-0137,50090-2514+6 - Aidarex Pharmaceuticals LLC:
53217-019 - American Health Packaging:
60687-811,60687-822,60687-833 - Aphena Pharma Solutions - Tennessee, Inc.:
43353-919,43353-124,43353-205,71610-549+5 - Bryant Ranch Prepack:
71335-2307,63629-8493,63629-8494,72162-1535+16 - Cardinal Health 107, LLC:
55154-9587,55154-9554,55154-5689,55154-0186+5 - Coupler Enterprises Inc.:
67046-270,67046-280 - Coupler LLC:
67046-1520,67046-1609,67046-2071,67046-1660+3 - Direct Rx:
72189-013,61919-312,61919-846 - HF Acquisition Co. LLC. DBA HealthFirst:
51662-1376,51662-1648,51662-1388 - Henry Schein, Inc.:
0404-9787 - Major Pharmaceuticals:
0904-7447,0904-7450,0904-7448,0904-7449 - Medical Purchasing Solutions, LLC.:
71872-7274,71872-7268,71872-7145,71872-7339 - Mylan Institutional Inc.:
51079-074,51079-075,51079-076 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-7973 - Northwind Pharmaceuticals:
82868-045 - NuCare Pharmaceuticals.Inc.:
68071-2055,68071-5285,68071-2530,68071-1940 - PD-Rx Pharmaceuticals, Inc.:
55289-133,43063-392 - Physicians Total Care, Inc.:
54868-5788,54868-0536,54868-6266,54868-1949+1 - Preferred Pharmaceuticals, Inc..:
68788-8087 - ProPharma Distribution:
84549-614 - Proficient Rx LP:
71205-091,82804-197,63187-901,82804-081+1 - Rebel Distributors Corp..:
21695-679,21695-695,21695-680,21695-694 - Remedyrepack Inc.:
70518-4022,70518-4352,70518-3659,70518-2551+3 - Safecor Health, LLC:
48433-046,48433-047,48433-048 - State of Florida DOH Central Pharmacy:
53808-0882,53808-1062
Recalls
- Mar 8, 2017 · Class II · Mckesson Medical Surgical
Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation. - Jul 28, 2015 · Class III · Fresenius Kabi USA, LLC
Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.