Glenmark Pharmaceuticals recalls 5mg Solifenacin tablets due to CGMP deviations. These prescription-only tablets (30-count and 90-count bottles) may have manufacturing issues.
CGMP Deviations
Glenmark Pharmaceuticals is recalling prescription Solifenacin Succinate 5mg tablets because of manufacturing deviations. This recall affects specific bottle sizes and expiration dates. The issue could lead to product quality problems, though serious injury risks are not described.
CGMP deviations refer to manufacturing process issues that could affect product quality. These tablets are prescription-only and may not be safe for use if they contain impurities or inconsistencies in the medication.
Prescription users who have the 30-count or 90-count bottles with NDC numbers 68462-386-30 or 68462-386-90. People taking this medication for overactive bladder should check their bottles.
Check for the 30-count or 90-count bottles labeled with NDC numbers 68462-386-30 or 68462-386-90. The expiration date is November 2025 for both bottle sizes.
Look for the 30-count or 90-count bottles with NDC numbers 68462-386-30 or 68462-386-90.
The recall is for CGMP deviations, which could affect product quality. Serious injury risks are not described in the notice.
The recall notice does not specify a remedy, so you should contact your doctor or pharmacist for advice.
Check for the 30-count or 90-count bottles with NDC numbers 68462-386-30 or 68462-386-90. The expiration date is November 2025.
We’ve drafted a message you can send Glenmark Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0333-2025 — Glenmark Pharmaceuticals Glenmark Pharmaceuticals Hello, I own a Glenmark Pharmaceuticals that is covered by recall D-0333-2025 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.
