Fesoterodine Tablets (Alembic) – Impurity Levels (2025)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Alembic Pharmaceuticals Limited
Lot Codes / Batch Numbers
Lot # 2405006633, Exp Date: 03/31/2026
Products Sold
Lot # 2405006633, Exp Date: 03/31/2026
Alembic Pharmaceuticals Limited is recalling Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Al due to Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 7, 2026
Important Notice
This page displays information sourced from the U.S. Food and Drug Administration (FDA). IsMyProductRecalled.com aggregates public data for convenience and does not issue recalls. We are not affiliated with any government agency. Always verify recall information with the official source before taking action. This is not medical or legal advice.