Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets

Alembic Pharmaceuticals Limited has recalled Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on January 14, 2026 and was initiated on December 16, 2025. It is classified as a Class III recall, which means using this product is not likely to cause health problems, but it breaks an FDA rule (for example, a labeling or packaging issue).

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets. The company behind the recall is Alembic Pharmaceuticals Limited, based in Panchmahal. The FDA describes the product as: “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”

Why was Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets recalled?

According to the FDA, the stated reason for the recall is: “Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.” In plain terms, this recall relates to a chemical impurity.

This recall involves an unwanted chemical detected in the medicine — often a nitrosamine impurity, which regulators limit because long-term exposure above set levels may increase health risks. Regulators recall affected batches as a precaution. Health authorities generally advise talking to a doctor or pharmacist before stopping a prescribed medicine.

What should you do?

If you think you may have bought Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, compare it against the product description and identifying codes (Lot# 2405003360, Exp Date: Jan 31, 2026) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Alembic Pharmaceuticals Limited or your local health authority.

About this recall

This recall was distributed in US Nationwide and PR.. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.