Information
Alembic Pharmaceuticals Limited Recalls Fesoterodine Fumarate
This is a Class III recall. This product is unlikely to cause adverse health reactions but violates FDA regulations.
Source: FDA
InfoRecall #D-0156-2026Drug / Pharmaceutical
Alembic Pharmaceuticals Limited Recalls Fesoterodine Fumarate
Alembic Pharmaceuticals Limited · Class III — Regulatory
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.
FDA Classification
Class III — Regulatory
A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Distribution
Nationwide in the USA.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
Alembic Pharmaceuticals Limited initiated a Class III recall of a pharmaceutical product on October 10, 2025 affecting 4,884 30-count bottles. Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. Class III recalls involve products that are unlikely to cause adverse health reactions but violate FDA regulations. The product was distributed nationwide. Consumers may continue monitoring FDA updates regarding this recall.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.