Fesoterodine Fumarate recall
FDA recall D-0156-2026 · initiated Oct 10, 2025
Alembic Pharmaceuticals Limited recalled Fesoterodine Fumarate in Oct 2025 — an FDA Class III recall (D-0156-2026) because Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 4,884 30-count bottles
Details
- Product
- 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
- Recalling company
- Alembic Pharms Ltd
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA.
- Initiated
- Oct 10, 2025
- FDA report date
- Nov 26, 2025
Frequently asked
- Was Fesoterodine Fumarate recalled?
- Alembic Pharmaceuticals Limited recalled Fesoterodine Fumarate in Oct 2025 — an FDA Class III recall (D-0156-2026) because Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Fesoterodine Fumarate recalled?
- Per the FDA enforcement record, the reason for recall D-0156-2026 was: Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
- Is a recalled Fesoterodine Fumarate dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Fesoterodine Fumarate are affected?
- Distributed: Nationwide in the USA.. The recall covers these lots — Lot # 2405006633, Exp Date: 03/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0156-2026.