Antihistamine
Where is Hydroxyzine made?
26 companies sell it under their own name and 47 repackagers rebottle it. Their labels name 20 factories in the United States and India.
United States 12India 8
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Amneal Pharmaceuticals10 mg, 25 mg, 50 mg · NDC 65162-575, 0115-1670, 65162-671 +4 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyJan 2025 |
| Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | No problems foundJul 2024 | |
| Patheon Pharmaceuticals Inc.Makes it, tests it, packages it and labels it | Cincinnati, OH, United States | Problems found, fixed voluntarilySep 2025 | |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.10 mg, 25 mg, 50 mg · NDC 23155-500, 23155-501, 14539-674 +2 | CorePharma, LLCMakes it, tests it, packages it and labels it | Middlesex, NJ, United States | No problems foundAug 2025 |
| Emcure Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Surendranagar, India | No problems foundOct 2025 | |
| Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.Makes it, tests it, packages it and labels it | East Brunswick, NJ, United States | No problems foundSep 2023 | |
| ANI Pharmaceuticals, Inc.10 mg per 5 mL · NDC 70954-912 | Novitium Pharma LLCMakes it, tests it, packages it and labels it | East Windsor, NJ, United States | No problems foundFeb 2024 |
| American Regent, Inc.25 mg per 1 mL, 50 mg per 1 mL · NDC 0517-4201, 0517-5601, 0517-5602 +1 | American Regent, Inc.Makes it and tests it | Shirley, NY, United States | Problems found, fixed voluntarilyApr 2024 |
| Apozeal Pharmaceuticals Inc.10 mg per 5 mL · NDC 83745-232 | Apozeal Pharmaceuticals IncMakes it, tests it and packages it | Levittown, PA, United States | Serious problems, FDA actionOct 2025 |
| Aurobindo Pharma Limited10 mg, 25 mg, 50 mg · NDC 59651-499, 59651-500, 59651-501 | Apl Healthcare LimitedMakes it and tests it | Mahabubnagar, India | No problems foundJan 2023 |
| Bionpharma Inc.10 mg per 5 mL · NDC 69452-395 | OrBion Pharmaceuticals Private LimitedMakes it | Kancheepuram, India | No problems foundOct 2025 |
| Camber Pharmaceuticals Inc.10 mg, 25 mg, 50 mg · NDC 31722-500, 31722-501, 31722-502 | Hetero Labs LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 |
| Chartwell RX, LLC.10 mg, 10 mg per 5 mL, 25 mg, 50 mg, 50 mg per 25 mL · NDC 62135-545, 62135-573, 62135-502 +8 | Chartwell Pharmaceuticals Carmel, LLC.Makes it, tests it, packages it and labels it | Carmel, NY, United States | Problems found, fixed voluntarilyOct 2022 |
| Epic Pharma, LLC10 mg, 25 mg, 50 mg · NDC 42806-159, 42806-160, 42806-161 | Epic Pharma, LLCMakes it | Laurelton, NY, United States | Problems found, fixed voluntarilyJun 2026 |
| H.J. Harkins Co., Inc.10 mg · NDC 52959-481 | H.J. Harkins Company, Inc.Makes it, repackages it and relabels it | Grover Beach, California, United States | Problems found, fixed voluntarilyMar 2023 |
| KVK-TECH, Inc.10 mg, 25 mg, 50 mg · NDC 10702-010, 10702-011, 10702-012 | Kvk-Tech, Inc.Makes it | Newtown, PA, United States | Serious problems, FDA actionMar 2025 |
| Morton Grove Pharmaceuticals, Inc.10 mg per 5 mL · NDC 60432-150 | Morton Grove Pharmaceuticals, Inc.Makes it, tests it, packages it and labels it | Morton Grove, Illinois, United States | Serious problems, FDA actionFeb 2016 |
| Northstar Rx LLC.10 mg, 25 mg, 50 mg · NDC 16714-081, 16714-082, 16714-083 | Piramal Pharma LimitedMakes it, tests it and packages it | Pithampur, India | No problems foundMay 2023 |
| PuraCap Laboratories LLC dba Blu Pharmaceuticals10 mg, 25 mg, 50 mg · NDC 24658-781, 24658-782, 24658-783 | Epic Pharma, LLCMakes it | Laurelton, NY, United States | Problems found, fixed voluntarilyJun 2026 |
| Rising Pharma Holdings, Inc.10 mg, 25 mg, 50 mg · NDC 16571-113, 16571-114, 16571-115 | Graviti Pharmaceuticals Private LimitedMakes it and tests it | Sangareddy, India | Problems found, fixed voluntarilyJul 2026 |
| Saptalis Pharmaceuticals, LLC.10 mg per 5 mL · NDC 71656-090 | Saptalis Pharmaceuticals LLCMakes it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMar 2026 |
| Advagen Pharma Ltd.10 mg per 5 mL · NDC 72888-218 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Caraco Pharmaceutical Laboratories, Ltd.10 mg, 25 mg, 50 mg · NDC 57664-112, 57664-113, 57664-114 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell Governmental & Specialty RX, LLC.50 mg per 25 mL · NDC 68999-050 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Lannett Company, Inc.10 mg per 5 mL · NDC 54838-502 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Marlex Pharmaceuticals, Inc.10 mg, 25 mg, 50 mg · NDC 10135-810, 10135-811, 10135-812 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Pharmaceutical Associates, Inc.10 mg per 5 mL · NDC 0121-1034 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc.25 mg, 50 mg · NDC 0185-0674, 0185-0613, 0185-0615 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sunrise Pharmaceutical, Inc.10 mg, 25 mg, 50 mg · NDC 11534-204, 11534-205, 11534-206 | 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 0093-5060, 0555-0324, 0555-0323 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Hydroxyzine 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:
50090-4117,50090-2818,50090-6682,50090-8119+32 - Advanced Rx Pharmacy of Tennessee, LLC:
80425-0365,80425-0590,80425-0173,80425-0376+1 - Aidarex Pharmaceuticals LLC:
53217-236,33261-161,53217-256,33261-858+2 - American Health Packaging:
60687-664,60687-696,60687-675,60687-707+1 - Aphena Pharma Solutions - Tennessee, Inc.:
71610-397,71610-217,71610-686,71610-735+6 - Apotheca, Inc.:
12634-833 - Asclemed USA, Inc.:
76420-881,76420-922,76420-882,76420-920+2 - Atlantic Biologicals Corps.:
17856-0150,17856-0507 - AvPAK:
50268-398,50268-399 - Blenheim Pharmacal, Inc.:
10544-209,10544-043,10544-091,10544-210+4 - Bryant Ranch Prepack:
71335-1121,71335-0268,72162-1332,72162-2511+36 - Cardinal Health 107, LLC:
55154-2337,55154-2148 - Carilion Materials Management:
68151-0150 - Coupler Enterprises Inc.:
67046-281,67046-713,67046-282,67046-279+1 - Coupler LLC:
67046-1036,67046-0833,67046-1398,67046-2086+6 - Denton Pharma, Inc. DBA Northwind Pharmaceuticals.:
70934-233,70934-324,70934-444,70934-234+6 - Direct Rx:
61919-646,72189-333,61919-122,61919-217+11 - Dispensing Solutions Inc.:
66336-086 - Golden State Medical Supply, Inc.:
51407-969,51407-970,51407-001,51407-971+1 - H.J. Harkins Co., Inc.:
52959-074,52959-433 - HF Acquisition Co. LLC. DBA HealthFirst:
51662-1649 - Henry Schein, Inc.:
0404-9877,0404-9878 - Kesin Pharma Corporation:
81033-031 - Liberty Pharmaceuticals, Inc.:
0440-1617 - Life Line Home Care Services, Inc.:
75921-011 - Major Pharmaceuticals:
0904-7377,0904-7065,0904-7378,0904-7379 - Medsource Pharmaceuticals:
45865-675 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8563,0615-8419,0615-8082,0615-8420+1 - Northwind Pharmaceuticals:
51655-078,51655-076,51655-079,51655-080+7 - NuCare Pharmaceuticals.Inc.:
68071-4633,68071-2864,68071-4499,68071-3980+18 - PD-Rx Pharmaceuticals, Inc.:
72789-271,43063-960,43063-943,43063-406+10 - Pharmasource Meds, LLC:
82982-032 - Physicians Total Care, Inc.:
54868-0229,54868-2032,54868-4336,54868-0063+3 - Preferred Pharmaceuticals, Inc..:
68788-8716,68788-4150,68788-8872,68788-8119+5 - Proficient Rx LP:
71205-541,82804-288,63187-494,71205-558+10 - RPK Pharmaceuticals, Inc.:
53002-3901,53002-3200,53002-3900,53002-6211+3 - Rebel Distributors Corp..:
21695-378,21695-208,21695-573,21695-356 - RedPharm Drug Inc.:
67296-0055,67296-0381,67296-0152 - RedPharm Drug. Inc.:
67296-0648,67296-1009,67296-1293,67296-1096+7 - Remedyrepack Inc.:
70518-2807,70518-4360,70518-2769,70518-2066+13 - St. Mary's Medical Park Pharmacy:
60760-285,60760-971,60760-990 - Stat Rx USA:
42549-528,16590-357,16590-737 - State of Florida DOH Central Pharmacy:
53808-0431,53808-0426,53808-0373,53808-0886+5 - TYA Pharmaceuticals:
64725-0323,64725-0800,64725-0169,64725-1690+3 - Unit Dose Services:
50436-3874,50436-0501 - Unit Dose Solutions, Inc.:
87441-040,87441-087,87441-041,87441-042+1 - Westwood Manufacturing:
42495-170
Recalls
- Jun 2, 2026 · Class III · ANI Pharmaceuticals, Inc.
Presence of foreign substance - Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse - Dec 9, 2020 · Class II · Morton Grove Pharmaceuticals, Inc.
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities. - Oct 11, 2018 · Class II · Lannett Company, Inc.
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities. - Jan 24, 2014 · Class II · Teva Pharmaceuticals USA
CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing. - Jan 24, 2014 · Class II · Teva Pharmaceuticals USA
CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing. - Dec 11, 2013 · Class II · KVK-Tech, Inc. · 3 recall notices
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.