Indomethacin recalls

Indomethacin products have been recalled 7 times, most recently on 11 Jun 2025. The recalling company is usually Glenmark Pharmaceuticals Inc., U. The most common reason is manufacturing (cgmp) deviations.

Total recalls7since 2018

Last 12 months0reported

Class I00% of total

Ongoing5latest 11 Jun 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 1Apr 1 1 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 6 86%Class III 1 14%

Why indomethacin is recalled

Companies

By year

2025343%
2024114%
2023114%
2018229%

Ongoing indomethacin recalls

5 active

Reported	Class	Recall	Company	Reason	Where
11 Jun 2025Drug	CLASS II	Indomethacin Extended-Release Capsules, USP, 75 mg recalledIndomethacin	Amerisource Health Services	Manufacturing (CGMP) Deviations	Nationwide
28 May 2025Drug	CLASS II	Indomethacin Extended-Release Capsules USP, 75 mg recalled by KVK TechIndomethacin	KVK Tech	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Indomethacin Extended-Release Capsules, 75mg recalledIndomethacin	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
4 Sep 2024Drug	CLASS II	Indomethacin Extended-Release Capsules, USP, 75 mg recalledIndomethacin	Glenmark Pharmaceuticals Inc., U	Potency & Assay	Nationwide
6 Dec 2023Drug	CLASS II	Indomethacin 25mg Capsules recalled by Glenmark PharmaceuticalsIndomethacin	Glenmark Pharmaceuticals Inc., U	Packaging Defects	Nationwide

All indomethacin recalls, newest first

7 total

Reported	Class	Recall	Company	Reason	Where
11 Jun 2025Drug	CLASS II	Indomethacin Extended-Release Capsules, USP, 75 mg recalledIndomethacin	Amerisource Health Services	Manufacturing (CGMP) Deviations	Nationwide
28 May 2025Drug	CLASS II	Indomethacin Extended-Release Capsules USP, 75 mg recalled by KVK TechIndomethacin	KVK Tech	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Indomethacin Extended-Release Capsules, 75mg recalledIndomethacin	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
4 Sep 2024Drug	CLASS II	Indomethacin Extended-Release Capsules, USP, 75 mg recalledIndomethacin	Glenmark Pharmaceuticals Inc., U	Potency & Assay	Nationwide
6 Dec 2023Drug	CLASS II	Indomethacin 25mg Capsules recalled by Glenmark PharmaceuticalsIndomethacin	Glenmark Pharmaceuticals Inc., U	Packaging Defects	Nationwide
8 Aug 2018Drug	CLASS II	Indomethacin Capsules, USP, 50 mg recalledIndomethacin	Hetero Labs, Ltd. - Unit III	Other	Nationwide
4 Apr 2018Drug	CLASS III	Indomethacin Capsules USP, 50 mg recalled by Glenmark PharmaceuticalsIndomethacin	Glenmark Pharmaceuticals Inc., U	Labeling Errors	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.