FDA-Drug2026-01-14Class IIICHEMICAL
Alembic Fesoterodine Fumarate 8 mg tablets recalled for excess impurities
What this means
Alembic Pharmaceuticals is recalling one lot of Fesoterodine Fumarate 8 mg extended-release tablets because testing found levels of a chemical impurity (diester impurity) that exceed safety limits. The affected lot is 2405003360, which expires January 31, 2026.
- Check if your Fesoterodine Fumarate 8 mg tablets match lot #2405003360.
- Do not use tablets from this lot. Stop taking them and contact your pharmacist or doctor.
- Return the tablets to your pharmacy or follow your doctor's instructions.
- Call your doctor before stopping this medication to discuss next steps.
The agency's original wording
Hazard
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide and PR.
Manufactured in
Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol, Panchmahal, India
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0248-2026Want us to check the next one for you?
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