Cholinergic Muscarinic Antagonist
Where is Oxybutynin made?
22 companies sell it under their own name and 31 repackagers rebottle it. Their labels name 15 factories in the United States, India and the United Arab Emirates.
United States 7India 7United Arab Emirates 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Rising Pharma Holdings, Inc.2.5 mg, 5 mg, 10 mg, 15 mg · NDC 64980-210, 64980-211, 64980-531 +4 | Appco Pharma LLCMakes it, tests it and packages it | Piscataway, NJ, United States | Problems found, fixed voluntarilyMay 2026 |
| Piramal Pharma LimitedMakes it, tests it and packages it | Pithampur, India | No problems foundMay 2023 | |
| Unique Pharmaceutical LaboratoriesMakes it | Bharuch, India | Problems found, fixed voluntarilyOct 2022 | |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.5 mg · NDC 23155-810, 23155-913 | 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 |
| Strides Pharma Science LimitedMakes it, tests it and packages it | Bengaluru, India | Problems found, fixed voluntarilyMay 2026 | |
| ANI Pharmaceuticals, Inc.5 mg · NDC 70954-005 | Novitium Pharma LLCMakes it, tests it, packages it and labels it | East Windsor, NJ, United States | No problems foundFeb 2024 |
| Accord Healthcare Inc.5 mg, 10 mg, 15 mg · NDC 16729-318, 16729-319, 16729-317 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | No problems foundJul 2024 |
| Advagen Pharma Ltd.5 mg, 10 mg, 15 mg · NDC 72888-031, 72888-032, 72888-030 | Rubicon Research LimitedMakes it, tests it, packages it and labels it | Thane, India | No problems foundMar 2024 |
| Ajanta Pharma USA Inc.5 mg, 10 mg, 15 mg · NDC 27241-156, 27241-157, 27241-155 | Ajanta Pharma LimitedMakes it | Chhatrapati Sambhajinagar, India | Problems found, fixed voluntarilyApr 2026 |
| Amneal Pharmaceuticals5 mg, 10 mg, 15 mg · NDC 65162-372, 65162-373, 65162-371 | Amneal Pharmaceuticals of New York, LLCMakes it, tests it, packages it and labels it | Brookhaven, NY, United States | No problems foundSep 2026 |
| Cadila Healthcare Limited5 mg, 10 mg, 15 mg · NDC 70771-1087, 70771-1088, 70771-1086 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Drug Ocean LLC5 mg · NDC 70985-021 | Unique Pharmaceutical LaboratoriesMakes it | Bharuch, India | Problems found, fixed voluntarilyOct 2022 |
| KVK-TECH, Inc.5 mg · NDC 10702-201 | Kvk-Tech, Inc.Makes it | Newtown, PA, United States | Serious problems, FDA actionMar 2025 |
| Leading Pharma, LLC5 mg · NDC 69315-182 | LIFEPharma FZEMakes it and tests it | Dubai, United Arab Emirates | Problems found, fixed voluntarilyNov 2022 |
| Strides Pharma Science Limited2.5 mg, 5 mg · NDC 64380-190, 64380-781, 64380-162 | Strides Pharma Science LimitedMakes it, tests it and packages it | Bengaluru, India | Problems found, fixed voluntarilyMay 2026 |
| TruPharma LLC.2.5 mg, 5 mg · NDC 52817-261, 52817-260 | Tulex Pharmaceuticals IncMakes it, tests it, packages it and labels it | Cranbury, NJ, United States | Problems found, fixed voluntarilyMar 2025 |
| Upsher-Smith Laboratories, Inc.5 mg · NDC 0832-0038 | Bora Pharmaceuticals Inc.Makes it and tests it | Maple Grove, MN, United States | Problems found, fixed voluntarilyAug 2022 |
| Zydus Pharmaceuticals (USA) Inc.5 mg, 10 mg, 15 mg · NDC 68382-256, 68382-257, 68382-255 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Allergan, Inc. Oxytrol3.9 mg per 1 d · NDC 0023-6153 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell Governmental & Specialty RX, LLC.5 mg per 5 mL · NDC 68999-520 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.5 mg, 5 mg per 5 mL, 10 mg, 15 mg · NDC 62135-508, 62135-509, 62135-507 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Lannett Company, Inc.5 mg, 10 mg, 15 mg · NDC 62175-271, 62175-272, 62175-270 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Lannett Company, Inc.5 mg per 5 mL · NDC 54838-510 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Marlex Pharmaceuticals, Inc.5 mg, 10 mg, 15 mg · NDC 10135-610, 10135-611, 10135-609 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.5 mg · NDC 50111-456 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Oxybutynin 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:
50090-4658,50090-5353,50090-4307,50090-6673+12 - Aidarex Pharmaceuticals LLC:
33261-342,53217-335 - American Health Packaging:
68084-610,60687-670,60687-899,68084-480 - Aphena Pharma Solutions - Tennessee, Inc.:
43353-769,71610-347,43353-284,43353-322+7 - Atlantic Biologicals Corps.:
17856-1491,17856-0092,17856-0149 - AvKARE, Inc.:
42291-634,42291-635,42291-456,42291-633 - AvPAK:
50268-628,50268-629,50268-627 - Avera McKennan Hospital:
69189-6605 - Blenheim Pharmacal, Inc.:
10544-559,10544-518 - Bryant Ranch Prepack:
63629-5484,71335-2121,71335-1690,71335-1160+5 - Cardinal Health 107, LLC:
55154-2632 - Carilion Materials Management:
68151-3646,68151-9200 - Coupler LLC:
67046-1600,67046-1599,67046-1381 - Denton Pharma, Inc. DBA Northwind Pharmaceuticals.:
70934-529 - Direct Rx:
72189-132,72189-130,72189-131 - Dispensing Solutions Inc.:
66336-604 - Golden State Medical Supply, Inc.:
51407-099 - Major Pharmaceuticals:
0904-6570,0904-7027 - Marlex Pharmaceuticals, Inc.:
10135-640 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8220,0615-8492,0615-8219 - Northwind Pharmaceuticals:
82868-047,51655-665 - NuCare Pharmaceuticals.Inc.:
66267-642 - PD-Rx Pharmaceuticals, Inc.:
43063-790,72789-049,72789-414,43063-851+3 - Physicians Total Care, Inc.:
54868-5728,54868-4502,54868-6171,54868-5743+4 - Preferred Pharmaceuticals, Inc..:
68788-8141 - Proficient Rx LP:
71205-667,82804-095,63187-749 - Rebel Distributors Corp..:
21695-406 - RedPharm Drug. Inc.:
67296-1175,67296-2045,67296-2335 - Remedyrepack Inc.:
70518-2640 - State of Florida DOH Central Pharmacy:
53808-0618,53808-0747,53808-0873,53808-1122 - Verityrx, LLC:
83939-0022
Recalls
- Oct 19, 2023 · Class II · Zydus Pharmaceuticals (USA) Inc · 3 recall notices
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point. - Sep 21, 2023 · Class II · Zydus Pharmaceuticals (USA) Inc
Failed Dissolution Specifications - Mar 1, 2019 · Class III · AVKARE Inc.
Failed Dissolution Specifications - Feb 21, 2019 · Class III · Lannett Company Inc.
Failed Dissolution Specifications - Dec 11, 2018 · Class II · KVK-Tech, Inc.
Labeling: Wrong bar code
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.