Glenmark Pravastatin 80mg Tablets Recall: Failed Dissolution Specifications
Glenmark Pharmaceuticals recalls 80mg Pravastatin Sodium Tablets due to failed dissolution specifications. These tablets may not work as intended. Check NDC numbers and expiration dates for affected lots.
Lower-risk recall
Failed Dissolution Specifications: results below specifications
Contact the company
What happened, in plain English
Glenmark Pharmaceuticals is recalling 80mg Pravastatin Sodium Tablets that failed dissolution tests. This means the medication may not work properly in the body, potentially reducing effectiveness. Affected products were sold with specific NDC numbers and expiration dates. Read more at govinfonow.com/recall/32601-glenmark-pravastatin-80mg-tablets-recall-failed-dissolution-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/32601-glenmark-pravastatin-80mg-tablets-recall-failed-dissolution-specifications · Updated August 17, 2026 · FDA enforcement record: FDA #D-0612-2024
Cite this page
“Glenmark Pravastatin 80mg Tablets Recall: Failed Dissolution Specifications.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32601-glenmark-pravastatin-80mg-tablets-recall-failed-dissolution-specifications. Based on FDA recall #D-0612-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0612-2024%22&limit=1).
Why it’s dangerous
The tablets failed to dissolve at the required rate, which could lead to reduced effectiveness. This means the medication might not work as intended to lower cholesterol levels. However, the risk is not immediate or life-threatening.
Who’s affected
People prescribed this medication by a doctor who received the recalled tablets. Those taking the medication for cholesterol management are most at risk if the tablets don't dissolve properly.
How to tell if you have this one
Check for NDC numbers 68462-198-90 (90-count bottle) or 68462-198-05 (500-count bottle). The expiration dates range from June 30, 2024, to January 31, 2025, depending on the lot.
- Brand
Glenmark- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC numbers 68462-198-90 or 68462-198-05 on the bottle and expiration dates listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 26 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this medication dangerous if taken?
The recall is due to failed dissolution specifications, which may reduce effectiveness but is not immediately dangerous. The medication is still safe to take if prescribed by a doctor.
Do I need to stop using this medication?
No, the recall does not require stopping use. However, you should check if you have the recalled product and contact your doctor if you're unsure.
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Where this comes from
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.
- Official source: FDA Recall #D-0612-2024 (June 28, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0612-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.