Drugs & medicalClass III

Alembic Pharmaceuticals Limited recalls Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals…

Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.

Date: 2025-11-26
Country: United States
Brand: Alembic Pharmaceuticals
Product: Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav…
Classification: Class III
Units: Nationwide in the USA.
Category: Drugs & medical
Source: FDA · Drug

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

Check the product name, strength and lot number against the official notice.
Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Alembic Pharmaceuticals recalls

2026-01-14
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Alembic Pharmaceuticals Limited recalls Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited,…
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
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All 7 Alembic Pharmaceuticals recalls →

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