Alembic recalls fesoterodine fumarate 4 mg extended-release tablets over high impurity levels
A impurity called 'Diester Impurity' was found at levels above the allowed limit in these bladder medicine tablets, so they failed quality testing for impurities and degradation.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall 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
- Hazard
- Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
- Units
- 4,884 30-count bottles
- Where sold
- Nationwide in the USA.
- FDA classification
- Class III · Ongoing
- Classified by FDA
- November 14, 2025
- Recall started
- October 10, 2025
- FDA enforcement report
- November 26, 2025
- Identifiers
- Codes: Lot # 2405006633, Exp Date: 03/31/2026
- FDA recall number: D-0156-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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
- Reason for recall
- Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
- Classification
- Class III (Ongoing)
- Distribution
- Nationwide in the USA.
- Quantity
- 4,884 30-count bottles
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