Drug recall D-0156-2026
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
Reason for recall
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Lots and codes
Lot # 2405006633, Exp Date: 03/31/2026
Recall details
- Recalling firm
- Alembic Pharmaceuticals Limited, Panchmahal
- Quantity
- 4,884 30-count bottles
- Distribution
- Nationwide in the USA.
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 10, 2025
Related products
- Fesoterodine Fumarate – drug information
- NDC 62332-176 Fesoterodine Fumarate · Fesoterodine Fumarate 8 mg/1 · Alembic Pharmaceuticals Inc.
- NDC 62332-175 Fesoterodine Fumarate · Fesoterodine Fumarate 4 mg/1 · Alembic Pharmaceuticals Inc.