Glenmark Pharmaceuticals recalls 75mg Indomethacin Extended-Release Capsules due to failed dissolution specifications. Rx-only capsules with NDC 68462-325-60 or 68462-325-90 may not release medication properly.
Failed Dissolution Specifications: below specification results
Glenmark Pharmaceuticals is recalling 75mg Indomethacin Extended-Release Capsules that failed dissolution testing. This means the medication may not release properly in the body, potentially reducing effectiveness. The capsules are prescription-only and sold in 60-count or 90-count bottles with specific NDC numbers.
The capsules failed dissolution testing, meaning they may not release the medication properly in the body. This could lead to reduced effectiveness of the drug, but does not cause immediate harm or serious injury. The issue is specific to the manufacturing batch and not a safety hazard.
Prescription patients who own the recalled 75mg Indomethacin Extended-Release Capsules in 60-count (NDC 68462-325-60) or 90-count (NDC 68462-325-90) bottles. Patients with arthritis or other conditions requiring this medication are most at risk of ineffective treatment.
Check for 75mg Indomethacin Extended-Release Capsules in 60-count (NDC 68462-325-60) or 90-count (NDC 68462-325-90) bottles. These are prescription-only capsules manufactured by Glenmark Pharmaceuticals Inc., USA.
Verify the NDC number on the bottle to confirm it's 68462-325-60 or 68462-325-90.
No, the recall is for reduced effectiveness due to failed dissolution testing, not a safety hazard. The capsules do not cause injury or serious health risks.
Check for 75mg Indomethacin Extended-Release Capsules in 60-count (NDC 68462-325-60) or 90-count (NDC 68462-325-90) bottles.
No, the recall is for reduced effectiveness, not a safety hazard. Patients should continue using the capsules as directed but contact their doctor for alternative options.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0643-2024 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0643-2024 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.
