Drug recall D-0248-2026
Product
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
Reason for recall
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Lots and codes
Lot# 2405003360, Exp Date: Jan 31, 2026
Recall details
- Recalling firm
- Alembic Pharmaceuticals Limited, Panchmahal
- Distribution
- US Nationwide and PR.
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 16, 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.