Indomethacin Extended-Release Capsules recall
FDA recall D-0643-2024 · initiated Jul 31, 2024
Glenmark Pharmaceuticals Inc., USA recalled Indomethacin Extended-Release Capsules in Jul 2024 — an FDA Class II recall (D-0643-2024) because Failed Dissolution Specifications: below specification results.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Dissolution Specifications: below specification results
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2404 bottles
Details
- Product
- Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count bottle (NDC 68462-325-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2 Phase-2, Pharma Zone, SEZ, Pithampur, Dist-Dhar, Madya Pradesh - 454775, India Mfg Llc. No: 25/9/2010, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
- Recalling company
- Glenmark Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide USA
- Initiated
- Jul 31, 2024
- FDA report date
- Sep 4, 2024
Frequently asked
- Was Indomethacin Extended-Release Capsules recalled?
- Glenmark Pharmaceuticals Inc., USA recalled Indomethacin Extended-Release Capsules in Jul 2024 — an FDA Class II recall (D-0643-2024) because Failed Dissolution Specifications: below specification results. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Indomethacin Extended-Release Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0643-2024 was: Failed Dissolution Specifications: below specification results
- Is a recalled Indomethacin Extended-Release Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Indomethacin Extended-Release Capsules are affected?
- Distributed: Nationwide USA. The recall covers these lots — Lot#: 17240105, Exp 12/31/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0643-2024.