Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-176-30
| Source | FDA Drug Enforcement |
|---|---|
| Category | Drug |
| Severity | Low |
| Status | ongoing |
| Recall date | December 16, 2025 |
| Reported | January 14, 2026 |
| Recalling firm | Alembic Pharmaceuticals Limited |
| Country / region | India US Nationwide and PR. |
Hazard
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Affected products
- Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Ma
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