NDC 62332-176
Fesoterodine Fumarate 8 mg tablet, extended release
On the label: Alembic Pharmaceuticals Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Alembic Pharmaceuticals Limited | Panchmahal, India | Makes it | No problems foundJul 26, 2024 · 8 inspections |
Recalls
- Dec 16, 2025 · Class III · Alembic Pharmaceuticals Limited
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Lots: Lot# 2405003360, Exp Date: Jan 31, 2026 - Oct 10, 2025 · Class III · Alembic Pharmaceuticals Limited
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Lots: Lot # 2405006633, Exp Date: 03/31/2026
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Fesoterodine: every company that makes it
- Form
- tablet, extended release, oral
- Strength
- 8 mg
- Approval
- ANDA ANDA204973
- On the market since
- Jan 6, 2023
- Package NDCs
62332-176-1062332-176-3062332-176-9062332-176-91- Official label
- DailyMed (National Library of Medicine), updated Jun 17, 2025
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