Alembic Pharmaceuticals Limited is voluntarily recalling one lot of Fesoterodine Fumarate Extended-release Tablets (8 mg), a prescription medication used to treat overactive bladder. The recall was initiated because testing detected levels of a 'Diester Impurity' that exceed the approved safety specifications. This recall affects 30-count bottles distributed nationwide across the United States and Puerto Rico.
The presence of impurities above the specification limit may compromise the quality and safety of the medication over time. While this is a low-risk (Class III) recall, consumers should ensure they are not taking the affected batch to maintain the intended effectiveness of their treatment.
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Manufactured by Alembic Pharmaceuticals Limited in Gujarat, India.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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