Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Fesoterodine Fumarate Recalled by Alembic Pharmaceuticals Limited Due to Failed Impurities/Degradation Specifications: Due to levels of 'Diester...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Alembic Pharmaceuticals Limited directly.
Affected Products
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
Quantity: 4,884 30-count bottles
Why Was This Recalled?
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report