Anticholinergic, Antihistamine
Where is Benztropine made?
14 companies sell it under their own name and 17 repackagers rebottle it. Their labels name 7 factories in the United States, Portugal and India.
United States 5Portugal 1India 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Cipla USA., Inc.0.5 mg, 1 mg, 2 mg · NDC 69097-826, 69097-827, 69097-832 | InvaGen Pharmaceuticals, IncMakes it and tests it | Hauppauge, NY, United States | No problems foundOct 2023 |
| Excellium Pharmaceutical Inc.0.5 mg, 1 mg, 2 mg · NDC 64125-136, 64125-137, 64125-138 | Excellium Pharmaceutical Inc.Makes it | Location not on file | Not inspected on record |
| Fresenius Kabi, LLC1 mg per 1 mL · NDC 63323-970 | Fresenius Kabi USA, LLCMakes it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 |
| Hikma Pharmaceuticals USA Inc.1 mg per 1 mL · NDC 0143-9729, 0143-9233 | Hikma Farmaceutica (portugal), S.aMakes it, tests it, packages it and labels it | Terrugem Sintra, Portugal | Problems found, fixed voluntarilyApr 2023 |
| Leading Pharma, LLC0.5 mg, 1 mg, 2 mg · NDC 69315-136, 69315-137, 69315-138 | Leading Pharma, LLCMakes it | Fairfield, NJ, United States | Problems found, fixed voluntarilyOct 2024 |
| Quagen Pharmaceuticals LLC0.5 mg, 1 mg, 2 mg · NDC 70752-123, 70752-124, 70752-125 | Quagen Pharmaceuticals LLCMakes it and packages it | West Caldwell, NJ, United States | No problems foundApr 2026 |
| ScieGen Pharmaceuticals, Inc.0.5 mg, 1 mg, 2 mg · NDC 50228-225, 50228-226, 50228-227 | A&Z Pharmaceutical, Inc.Makes it | Hauppauge, NY, United States | Problems found, fixed voluntarilySep 2025 |
| Zydus Pharmaceuticals (USA) Inc.1 mg per 1 mL · NDC 68382-860 | Zydus Lifesciences LimitedMakes it and tests it | Vadodara, India | Serious problems, FDA actionApr 2024 |
| Chartwell RX, LLC.0.5 mg, 1 mg, 2 mg · NDC 62135-141, 62135-144, 62135-142 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Marlex Pharmaceuticals, Inc.0.5 mg, 1 mg, 2 mg · NDC 10135-813, 10135-814, 10135-815 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Navinta LLC1 mg per 1 mL · NDC 68475-512 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Par Health USA, LLC0.5 mg, 1 mg, 2 mg · NDC 0603-2433, 0603-2434, 0603-2435 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sunrise Pharmaceutical, Inc.0.5 mg, 1 mg, 2 mg · NDC 11534-167, 11534-168, 11534-169 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Wintac Limited1 mg per 1 mL · NDC 10858-011 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Benztropine 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:
50090-4082,50090-6022,50090-7017,50090-3883+1 - American Health Packaging:
68084-381,68084-388,68084-389 - Aphena Pharma Solutions - Tennessee, Inc.:
43353-913,43353-796,71610-502 - Bryant Ranch Prepack:
72162-2594,72162-2595,72162-1154,72162-2596 - Coupler Enterprises Inc.:
67046-042,67046-207,67046-043 - Coupler LLC:
67046-2433,67046-1674,67046-1205,67046-0041+2 - Direct Rx:
61919-128 - Dispensing Solutions Inc.:
66336-776 - Major Pharmaceuticals:
0904-7288,0904-7289,0904-7290 - Marlex Pharmaceuticals, Inc.:
10135-606,10135-607,10135-608 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8222,0615-8223,0615-8478 - Proficient Rx LP:
63187-840 - Rebel Distributors Corp..:
21695-286 - Remedyrepack Inc.:
70518-2732,70518-0577,70518-0132,70518-2677 - State of Florida DOH Central Pharmacy:
53808-0826,53808-1014,53808-0211,53808-0210+4 - TYA Pharmaceuticals:
64725-2434,64725-0012,64725-2435 - Unit Dose Solutions, Inc.:
87441-012
Recalls
- Jul 1, 2013 · Class II · Fresenius Kabi USA, LLC
Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.