Alembic recalls fesoterodine fumarate 8 mg extended-release tablets over too much of an impurity
Some of these bladder medicine tablets contain a level of an impurity called 'Diester Impurity' that is above the allowed limit, so they failed quality standards for impurities and breakdown.
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, 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
- Hazard
- Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
- Where sold
- US Nationwide and PR.
- FDA classification
- Class III · Ongoing
- Classified by FDA
- January 2, 2026
- Recall started
- December 16, 2025
- FDA enforcement report
- January 14, 2026
- Identifiers
- Codes: Lot# 2405003360, Exp Date: Jan 31, 2026
- FDA recall number: D-0248-2026
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, 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
- Reason for recall
- Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
- Classification
- Class III (Ongoing)
- Distribution
- US Nationwide and PR.
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