Glenmark Pharmaceuticals recalls 20mg Pravastatin tablets due to CGMP deviations. Affected lots expire March 2026. No remedy specified in official notice.
CGMP Deviations
Glenmark Pharmaceuticals is recalling 20mg Pravastatin Sodium Tablets in two bottle sizes due to manufacturing quality control issues. This recall means the medication may not be safe for use as intended.
CGMP deviations refer to manufacturing quality control failures that could affect the safety and effectiveness of the medication. This means the tablets might not work as intended or could cause harm when taken.
Prescription holders of the 20mg Pravastatin Sodium Tablets with NDC numbers 68462-196-05 or 68462-196-90 are affected. Patients taking this medication for cholesterol management are most at risk.
Check for the NDC numbers 68462-196-05 (500-count bottle) or 68462-196-90 (90-count bottle) on the product label. The tablets are prescription-only and expire by March 2026.
Look for the NDC numbers 68462-196-05 or 68462-196-90 on the product label to confirm if it's affected.
The recall is due to CGMP deviations, which are manufacturing quality control issues that could affect the safety and effectiveness of the medication.
The official notice does not specify a remedy, so contact your healthcare provider for guidance on next steps.
Yes, the affected lots expire by March 2026.
We’ve drafted a message you can send Glenmark Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0341-2025 — Glenmark Pharmaceuticals Glenmark Pharmaceuticals Hello, I own a Glenmark Pharmaceuticals that is covered by recall D-0341-2025 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.
