Alembic Pharmaceuticals recalls 8mg extended-release fesoterodine tablets due to diester impurity levels exceeding safety limits. This may pose health risks for patients using prescription medication.
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Alembic Pharmaceuticals is recalling 8mg extended-release fesoterodine tablets because they contain diester impurities at levels above safe limits. This could potentially cause health issues for patients taking the medication as prescribed.
The tablets contain diester impurities at levels that exceed the manufacturer's safety specifications. This could lead to potential health risks for patients taking the medication, though the exact health impact isn't specified in the recall notice.
Patients with a prescription for fesoterodine fumarate extended-release tablets from Alembic Pharmaceuticals are affected. Those using the medication for overactive bladder symptoms are most at risk.
Check for the product name 'Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets' with NDC 62332-176-30. The lot number is 2405003360 and expiration date is January 31, 2026.
Verify the product name, NDC number, and expiration date to confirm if your tablets are recalled.
The recall states that diester impurity levels exceed safety specifications, but the exact health risk isn't specified in the notice.
Check for the product name 'Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets' with NDC 62332-176-30 and lot number 2405003360.
The recall notice does not specify a remedy, so contact your healthcare provider for guidance.
We’ve drafted a message you can send Alembic Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0248-2026 — Alembic Pharmaceuticals Alembic Pharmaceuticals Hello, I own a Alembic Pharmaceuticals that is covered by recall D-0248-2026 from Alembic Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
