FDARecalled Nov 26, 2025 · #D-0156-2026
Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmace...
Hazard
Class III — low health risk
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Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. Classification: Class III Distribution: Nationwide in the USA.
Product details
- Product
- Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-175-30
- Type
- Drugs
- Manufacturer
- Alembic Pharmaceuticals Limited
- Model numbers
- 2405006633
- UPCs
- —