Class IIIReported 2025-11-26

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.

Recall Number

D-0156-2026

Classification

Class III

Status

Ongoing