FESOTERODINE FUMARATE
Recalling Firm / Manufacturer: Alembic Pharmaceuticals Limited
(Panchmahal, India)
FDA Recall Number: D-0248-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
FESOTERODINE FUMARATE
Generic Name
FESOTERODINE FUMARATE
Active Substance(s)
Fesoterodine Fumarate
Administration Route
Oral
National Drug Code (NDC)
62332-175
Total Quantity Recalled
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Full Product Description
Packaging specifications and labeling details
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
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class III
Current Action Status
Ongoing
FDA Enforcement Report Date
January 14, 2026
Firm Initiation Date
December 16, 2025
FDA Classification Date
Jan 02, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot# 2405003360, Exp Date: Jan 31, 2026
Distribution Information
Geographic scope of affected shipments
US Nationwide and PR.
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Advisory Notice
This Class III recall involves technical or packaging non-conformities that are not expected to cause adverse health consequences. Consult your pharmacist if you have questions.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0248-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508608UTCC