Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceutical
Summary
The FDA issued a Class III for Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, by Alembic Pharmaceuticals Limited. Reason: Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit..
Details
Source
Drug Recall
External ID
D-0156-2026
Action Date
2025-11-26
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot # 2405006633, Exp Date: 03/31/2026
Quantity Affected: 4,884 30-count bottles
Reason for Recall
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Distribution
Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-10
Company
Panchmahal
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 52 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Alembic Pharmaceuticals Limited has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Alembic Pharmaceuticals Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Alembic Pharmaceuticals Limited have FDA actions?
Alembic Pharmaceuticals Limited has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0156-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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