Fesoterodine Fumarate Tablet, Extended Release
FDA Recall NDC 62332-176
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Fesoterodine Fumarate (NDC 62332-176). A significant event, classified as Class III, was initiated on Dec 16, 2025 by Alembic Pharmaceuticals Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
December 2025 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Ongoing
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Dec 16, 2025
Jan 14, 2026
N/A
Recall Profile & Regulatory Data
Event ID
98119
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Alembic Pharmaceuticals Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide and PR.
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
Batch or Lot Expiration Information
Lot# 2405003360, Exp Date: Jan 31, 2026
Affected Packages Involved in this Recall
62332-175-30Product
62332-175-90Product
62332-175-91Product
62332-175-10Product
62332-176-30Product
62332-176-90Product
62332-176-91Product
62332-176-10Product
2405003360Product
October 2025 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Ongoing
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Oct 10, 2025
Nov 26, 2025
4,884 30-count bottles
Recall Profile & Regulatory Data
Event ID
97812
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Alembic Pharmaceuticals Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
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
Batch or Lot Expiration Information
Lot# 2405006633, Exp Date: 03/31/2026
Affected Packages Involved in this Recall
62332-175-30Product
62332-175-90Product
62332-175-91Product
62332-175-10Product
62332-176-30Product
62332-176-90Product
62332-176-91Product
62332-176-10Product
2405006633Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
