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-0248-2026Drug / Pharmaceutical
Alembic Pharmaceuticals Limited Recalls Fesoterodine Fumarate
Alembic Pharmaceuticals Limited · Class III — Regulatory
Product Description
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.
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
US Nationwide and PR.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA has classified this as a Class III recall — the lowest severity level — for a pharmaceutical product recalled by Alembic Pharmaceuticals Limited on December 16, 2025. Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. The product was distributed in US Nationwide and PR. Class III recalls typically involve products unlikely to cause health problems but that violate FDA manufacturing or labeling regulations.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.