United StatesFesoterodine fumarate extended‑release tablets, 8 mg, 30‑count (NDC 62332‑176‑30) manufactured by Alembic Pharmaceuticals Limited for Alembic Pharmaceuticals, Inc., Lot 2405003360, exp. Jan 31, 2026, sold nationwide in the U.S. and Puerto Rico, are affected. The firm recalled the lot because levels of a “diester impurity” exceed the product’s impurity/degradation specifications.
What's being recalled
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
Recalling firm: Alembic Pharmaceuticals Limited, Panchmahal, India.
How to identify it
Lot# 2405003360, Exp Date: Jan 31, 2026
The hazard
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide and PR.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)