US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Jul 31, 2024 (2 years ago)

Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Failed Dissolution Specifications: below specification results

What was recalled

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 firm
Glenmark Pharmaceuticals Inc., USA
NDC code
68462-325-60
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0643-2024

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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