Glenmark Pharmaceuticals recalls 10mg Solifenacin tablets due to CGMP deviations. Affected products include 30-count and 90-count bottles with specific NDC numbers. No remedy provided in official notice.
CGMP Deviations
Glenmark Pharmaceuticals is recalling 10mg Solifenacin Succinate tablets in 30-count and 90-count bottles due to manufacturing quality control issues. This recall does not pose an immediate safety risk to consumers but requires action to ensure product safety.
The recall is for CGMP (Current Good Manufacturing Practices) deviations, which means the tablets were produced without following standard quality control procedures. This could lead to inconsistent medication strength or safety issues, though the exact risk is not specified in the recall notice.
People who have purchased the recalled 10mg Solifenacin tablets from pharmacies or doctors. Those using the medication for overactive bladder symptoms are most at risk due to potential quality issues.
Check for the product name 'Solifenacin Succinate Tablets 10mg' in 30-count or 90-count bottles with NDC numbers 68462-387-30 or 68462-387-90. The products are prescription-only and expire by March 2025.
Look for the NDC numbers 68462-387-30 or 68462-387-90 on the bottle to confirm if it's affected.
The recall is due to CGMP deviations, which means the tablets were produced without following standard quality control procedures.
The official notice does not provide a remedy for this recall.
Check for the NDC numbers 68462-387-30 or 68462-387-90 on the bottle, which are specific to the recalled 10mg Solifenacin tablets.
We’ve drafted a message you can send Glenmark Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0317-2025 — Glenmark Pharmaceuticals Glenmark Pharmaceuticals Hello, I own a Glenmark Pharmaceuticals that is covered by recall D-0317-2025 from Glenmark 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.
