Alembic fesoterodine extended-release tablets recalled for impurity
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.
From the FDA notice · Read the official notice ↗ · All Alembic Pharmaceuticals recalls
What to do
- 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.
Is yours affected?
Compare your label or packaging with the recalled product.
- 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
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
Details
- Illnesses reported
- None reported
- Manufactured in
- Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol, Panchmahal, India
- Classification
- Class III
- Recall number
- D-0248-2026
In the FDA's words
- Description
- 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 Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. Lot# 2405003360, Exp Date: Jan 31, 2026 Distribution: US Nationwide and PR.
- Hazard
- Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.