Indomethacin recalls

The FDA has published 9 recalls involving Indomethacin since 2014. The latest was reported on 11 Jun 2025. Most were for manufacturing (cgmp) deviations. Glenmark Pharmaceuticals Inc., U has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls9since 2014

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 8 89%Class III 1 11%

Why indomethacin is recalled

Companies

By year

2025333%
2024111%
2023111%
2018222%
2014222%

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

9 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
21 May 2014Drug	CLASS II	Indomethacin Capsules USP, 50 mg, a) recalled by Teva Pharmaceuticals U	Teva Pharmaceuticals U	Manufacturing (CGMP) Deviations	Nationwide
21 May 2014Drug	CLASS II	Indomethacin Capsules USP, 25 mg recalled by Teva Pharmaceuticals U	Teva Pharmaceuticals U	Manufacturing (CGMP) Deviations	Nationwide

Should you stop taking Indomethacin?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.