D-0156-2026 Class III Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- November 26, 2025
- Initiation Date
- October 10, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,884 30-count bottles
Product Description
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.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot # 2405006633, Exp Date: 03/31/2026