Glenmark Pharmaceuticals recalls 67mg fenofibrate capsules due to CGMP deviations. This affects 100-count bottles with specific lot numbers and expiration dates.
CGMP Deviations
Glenmark Pharmaceuticals is recalling 67mg fenofibrate capsules because of manufacturing quality control issues. This recall affects prescription-only bottles with specific lot numbers and expiration dates.
CGMP deviations refer to manufacturing quality control issues that could affect the product's safety and effectiveness. These deviations may lead to potential risks for patients using the medication.
Prescription holders of the 67mg fenofibrate capsules with lot numbers 17230834 or 17230835 are affected. Those who have the product and are under medical supervision are most at risk.
Check for the 67mg fenofibrate capsules with NDC code 68462-580-01. Look for lot numbers 17230834 or 17230835 with expiration dates of March 2025.
Identify the lot number and expiration date on the bottle to confirm if it is part of the recall.
The recall is due to CGMP deviations, but the product is not safe for use as it may have quality control issues.
Check for the NDC code 68462-580-01 and lot numbers 17230834 or 17230835 with expiration dates of March 2025.
The recall does not specify a remedy, so contact your healthcare provider for guidance.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0314-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0314-2025 from Glenmark. 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.
