Prescription drug
Where is Fesoterodine made?
12 companies sell it under their own name and 3 repackagers rebottle it. Their labels name 10 factories in India, the United States, Ireland and Germany.
India 7United States 1Ireland 1Germany 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Pfizer Laboratories Div Pfizer Inc Toviaz4 mg, 8 mg · NDC 0069-0242, 0069-0244 | Pfizer Ireland Pharmaceuticals Unlimited CompanyMakes the active ingredient and tests it | Ringaskiddy, Ireland | Problems found, fixed voluntarilyOct 2024 |
| Pfizer Manufacturing Deutschland GmbHMakes it, tests it, packages it and labels it | Freiburg im Breisgau, Germany | Problems found, fixed voluntarilyJul 2025 | |
| Alembic Pharmaceuticals Inc.4 mg, 8 mg · NDC 62332-175, 62332-176 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited4 mg, 8 mg · NDC 46708-175, 46708-176 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Amneal Pharmaceuticals4 mg, 8 mg · NDC 65162-369, 65162-370 | Amneal Pharmaceuticals of New York, LLCMakes it, tests it, packages it and labels it | Brookhaven, NY, United States | No problems foundSep 2026 |
| Ascend Laboratories, LLC4 mg, 8 mg · NDC 67877-064, 67877-068 | Alkem Laboratories LimitedMakes it | Baddi Solan, India | Problems found, fixed voluntarilyMar 2024 |
| Aurobindo Pharma Limited4 mg, 8 mg · NDC 65862-766, 65862-767 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Cadila Healthcare Limited4 mg, 8 mg · NDC 70771-1168, 70771-1169 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Camber Pharmaceuticals Inc.4 mg, 8 mg · NDC 31722-033, 31722-034 | Annora Pharma Private LimitedMakes it and tests it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Dr. Reddy's Laboratories Inc.4 mg, 8 mg · NDC 43598-247, 43598-248 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Medchal-Malkajgiri, India | Problems found, fixed voluntarilyOct 2023 |
| Lupin Pharmaceuticals, Inc.4 mg, 8 mg · NDC 68180-618, 68180-619 | Lupin LimitedMakes it | Salcette, India | Problems found, fixed voluntarilyNov 2025 |
| Northstar Rx LLC.4 mg, 8 mg · NDC 72603-413, 72603-414 | Annora Pharma Private LimitedMakes it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Zydus Pharmaceuticals (USA) Inc.4 mg, 8 mg · NDC 68382-479, 68382-480 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
Repackaged by
These companies buy Fesoterodine 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.
- Avera McKennan Hospital:
69189-0242,69189-0244 - Golden State Medical Supply, Inc.:
51407-661,51407-662 - Physicians Total Care, Inc.:
54868-6156,54868-6175
Recalls
- Dec 16, 2025 · Class III · Alembic Pharmaceuticals Limited
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. - Oct 10, 2025 · Class III · Alembic Pharmaceuticals Limited
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.