Central alpha-2 Adrenergic Agonist
Where is Clonidine made?
31 companies sell it under their own name and 39 repackagers rebottle it. Their labels name 11 factories in India, the United States, Portugal and China.
India 5United States 2Portugal 2China 2
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Alembic Pharmaceuticals Inc.0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg · NDC 62332-169, 62332-054, 62332-055 +1 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals LimitedMakes it | Vadodara, India | Problems found, fixed voluntarilyNov 2024 | |
| Alembic Pharmaceuticals Limited0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg · NDC 46708-169, 46708-306, 46708-307 +1 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals LimitedMakes it | Vadodara, India | Problems found, fixed voluntarilyNov 2024 | |
| Ajanta Pharma USA Inc.0.1 mg · NDC 27241-108 | Ajanta Pharma LimitedMakes it | Chhatrapati Sambhajinagar, India | Problems found, fixed voluntarilyApr 2026 |
| Aurobindo Pharma Limited0.1 mg, 0.2 mg, 0.3 mg · NDC 59651-232, 59651-233, 59651-234 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| BluePoint Laboratories.0.1 mg, 0.2 mg, 0.3 mg · NDC 68001-237, 68001-568, 68001-238 +1 | Ajanta Pharma LimitedMakes it | Chhatrapati Sambhajinagar, India | Problems found, fixed voluntarilyApr 2026 |
| H.J. Harkins Co., Inc.0.1 mg · NDC 52959-718 | H.J. Harkins Company, Inc.Makes it, repackages it and relabels it | Grover Beach, California, United States | Problems found, fixed voluntarilyMar 2023 |
| Hikma Pharmaceuticals USA Inc.100 ug per 1 mL, 500 ug per 1 mL · NDC 0143-9724, 0143-9723 | Hikma Farmaceutica (portugal), S.aMakes it | Terrugem Sintra, Portugal | Problems found, fixed voluntarilyApr 2023 |
| Ingenus Pharmaceuticals, LLC0.1 mg · NDC 50742-247 | Novast Laboratories Ltd.Makes it, tests it, packages it and labels it | Nantong, China | Problems found, fixed voluntarilyJul 2023 |
| Lupin Pharmaceuticals, Inc.0.1 mg · NDC 68180-606 | Lupin LimitedMakes it and packages it | Nagpur, India | Problems found, fixed voluntarilyJul 2023 |
| Mayne Pharma Inc.0.1 mg per 24 h, 0.2 mg per 24 h, 0.3 mg per 24 h · NDC 51862-453, 51862-454, 51862-455 | Corium Innovations, Inc.Makes it, tests it and packages it | Grand Rapids, MI, United States | Problems found, fixed voluntarilyNov 2022 |
| Solco Healthcare U.S., LLC0.1 mg, 0.100 mg, 0.200 mg, 0.300 mg · NDC 43547-435, 43547-565, 43547-566 +1 | Xiamen LP Pharmaceutical Co., Ltd.Makes it, tests it, packages it and labels it | Xiamen, China | Problems found, fixed voluntarilyApr 2024 |
| Somerset Therapeutics, LLC0.1 mg · NDC 70069-044 | Bluepharma - IndÚstria FarmacÊutica, S.a.Makes it, tests it, packages it and labels it | Coimbra, Portugal | Problems found, fixed voluntarilyMay 2025 |
| Xiamen LP Pharmaceutical Co., Ltd.0.1 mg · NDC 71034-001 | Xiamen LP Pharmaceutical Co., Ltd.Makes it, tests it, packages it and labels it | Xiamen, China | Problems found, fixed voluntarilyApr 2024 |
| Actavis Pharma, Inc.0.1 mg, 0.1 mg per 1 d, 0.2 mg, 0.2 mg per 1 d, 0.3 mg, 0.3 mg per 1 d · NDC 0228-4241, 0228-2127, 0591-3508 +4 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) Javadin20 ug per 1 mL · NDC 24338-115 | The label doesn't name the factory. Plants this company names for other drugs | ||
| CMP Pharma, Inc. Qlonilik0.05 mg per 1 mL · NDC 46287-085 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Dr. Reddy's Laboratories Inc.0.1 mg per 24 h, 0.2 mg per 24 h, 0.3 mg per 24 h · NDC 75907-023, 75907-024, 75907-025 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Marlex Pharmaceuticals, Inc.0.1 mg, 0.2 mg, 0.3 mg · NDC 10135-708, 10135-709, 10135-710 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Method Pharmaceuticals, LLC.0.1 mg, 0.2 mg, 0.3 mg · NDC 58657-647, 58657-648, 58657-649 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mutual Pharmaceutical Company, Inc.0.1 mg, 0.2 mg, 0.3 mg · NDC 53489-215, 53489-216, 53489-217 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Institutional LLC Duraclon0.1 mg per 1 mL · NDC 67457-218 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.0.1 mg per 1 d, 0.2 mg per 1 d, 0.3 mg per 1 d · NDC 0378-0871, 0378-0872, 0378-0873 | The label doesn't name the factory. Plants this company names for other drugs | ||
| NextWave Pharmaceuticals, Inc Onyda XR0.1 mg per 1 mL · NDC 24478-148 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Palmetto Pharmaceuticals Inc.0.17 mg · NDC 68134-603 | The label doesn't name the factory. Plants this company names for other drugs | ||
| PharmaForce, Inc.100 ug per 1 mL, 500 ug per 1 mL · NDC 40042-052, 40042-053 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Richmond Pharmaceuticals, Inc.0.1 mg, 0.2 mg, 0.3 mg · NDC 54738-907, 54738-908, 54738-909 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Rosemont Pharmaceuticals, LLC Nexiclon XR0.17 mg · NDC 71511-503 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Technomed Inc. Catapres-TTS-1, Catapres-TTS-2, Catapres-TTS-30.1 mg per 1 d, 0.2 mg per 1 d, 0.3 mg per 1 d · NDC 82089-201, 82089-101, 82089-202 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| TruPharma LLC.0.05 mg, 0.1 mg, 0.1 mg per 1 d, 0.17 mg, 0.2 mg, 0.2 mg per 1 d · NDC 52817-183, 52817-180, 52817-505 +8 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Unichem Pharmaceuticals (USA), Inc.0.1 mg, 0.2 mg, 0.3 mg · NDC 29300-468, 29300-135, 29300-136 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| XGen Pharmaceuticals DJB, Inc.100 ug per 1 mL, 500 ug per 1 mL · NDC 39822-2000, 39822-2010 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Clonidine 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:
50090-3824,50090-2775,50090-5103,50090-7009+9 - Aidarex Pharmaceuticals LLC:
33261-495,53217-215,33261-623 - American Health Packaging:
60687-113,60687-462,60687-124 - Aphena Pharma Solutions - Tennessee, Inc.:
43353-316,71610-449 - Apotheca, Inc.:
12634-465 - Asclemed USA, Inc.:
76420-066,76420-283,87063-181,76420-285+3 - AvPAK:
50268-192,50268-193,50268-194 - Blenheim Pharmacal, Inc.:
10544-196,10544-199,10544-042,10544-158 - Bryant Ranch Prepack:
71335-0121,71335-2266,72162-1367,71335-0777+25 - Cardinal Health 107, LLC:
55154-2576,55154-0189,55154-2577 - Clinical Solutions Wholesale:
58118-0072,58118-0073 - Coupler Enterprises Inc.:
67046-095,67046-094 - Coupler LLC:
67046-1033,67046-1475,67046-0327,67046-1552+3 - Denton Pharma, Inc. DBA Northwind Pharmaceuticals.:
70934-793 - Direct Rx:
61919-266,61919-718,61919-605,61919-267+1 - Dispensing Solutions Inc.:
55045-1167,66336-786 - HF Acquisition Co. LLC. DBA HealthFirst:
51662-1346 - Major Pharmaceuticals:
0904-7442,0904-7443 - Med Health Pharma, LLC:
51138-017,51138-018,51138-019 - MedVantx, Inc.:
66116-359,66116-521 - Medsource Pharmaceuticals:
45865-797 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-2572,0615-8272,0615-2574 - Northwind Pharmaceuticals:
51655-353,51655-445,51655-962,51655-362+2 - NuCare Pharmaceuticals.Inc.:
68071-2631,66267-061,68071-4661,68071-2699+7 - PD-Rx Pharmaceuticals, Inc.:
43063-817,72789-091,43063-925,43063-924 - Physicians Total Care, Inc.:
54868-0048,54868-6310,54868-0049,54868-6214+2 - Preferred Pharmaceuticals, Inc..:
68788-8494,68788-7145,68788-8080,68788-8163 - Proficient Rx LP:
63187-202,71205-570,71205-588,71205-218+1 - RPK Pharmaceuticals, Inc.:
53002-4141,53002-4140,53002-4941,53002-4940 - Rebel Distributors Corp..:
21695-371,21695-567,21695-372,21695-377 - RedPharm Drug. Inc.:
67296-0685,67296-1196,67296-2120,67296-2260+1 - Remedyrepack Inc.:
70518-3162,70518-1962,70518-1035,70518-4342+5 - St. Mary's Medical Park Pharmacy:
60760-057,60760-992 - Stat Rx USA:
16590-266,16590-267 - State of Florida DOH Central Pharmacy:
53808-0352,53808-0229,53808-0943,53808-0231+4 - TYA Pharmaceuticals:
64725-0215,64725-2957 - Unit Dose Services:
50436-3526 - Unit Dose Solutions, Inc.:
87441-023,87441-024 - Verityrx, LLC:
83939-0006,83939-0005
Recalls
- Mar 19, 2026 · Class II · Teva Pharmaceuticals USA, Inc · 3 recall notices
CGMP Deviations: use of an unapproved raw material - Sep 19, 2022 · Class III · Unichem Pharmaceuticals Usa Inc
Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets, - Jun 9, 2022 · Class II · Mayne Pharma Inc
Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint. - Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse - Oct 28, 2021 · Class III · Teva Pharmaceuticals USA
Failed Impurities/Degradation Specifications - May 26, 2020 · Class III · Unichem Pharmaceuticals Usa Inc
Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container. - Jan 29, 2020 · Class III · Unichem Pharmaceuticals Usa Inc
Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into product from container label. - Mar 29, 2019 · Class III · X-Gen Pharmaceuticals Inc.
Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL. - Jul 9, 2015 · Class II · Mutual Pharmaceutical Company, Inc. · 3 recall notices
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer - Jul 17, 2014 · Class III · X-Gen Pharmaceuticals Inc.
Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each mL contains 500 mcg Clonidine Hydrochloride" instead of stating "Each mL contains 100 mcg Clonidine Hydrochloride".
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.