Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by:...
FDA Recall #D-0156-2026 — Class III — October 10, 2025
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.
Recalling Firm
Alembic Pharmaceuticals Limited — Panchmahal
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
4,884 30-count bottles
Distribution
Nationwide in the USA.
Code Information
Lot # 2405006633, Exp Date: 03/31/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated