Mesalamine recalls

Mesalamine products have been recalled 4 times, most recently on 6 Mar 2024. The recalling company is usually Teva Pharmaceuticals U. The most common reason is potency & assay.

Total recalls4since 2020

Last 12 months0reported

Class I00% of total

Ongoing1latest 6 Mar 2024

Recalls per month, last 24 months

click a bar for that month

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

Severity split

Class I 0 0%Class II 4 100%Class III 0 0%

Why mesalamine is recalled

Potency & Assay375%
Sterility125%

Companies

Teva Pharmaceuticals U250%
Sun Pharmaceutical Industries250%

By year

2024250%
2020250%

Ongoing mesalamine recalls

1 active

Reported	Class	Recall	Company	Reason	Where
6 Mar 2024Drug	CLASS II	Mesalamine Extended-Release Capsules, USP 500mg recalledMesalamine	Sun Pharmaceutical Industries	Potency & Assay	Nationwide

All mesalamine recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
6 Mar 2024Drug	CLASS II	Mesalamine Extended-Release Capsules, USP 500mg recalledMesalamine	Sun Pharmaceutical Industries	Potency & Assay	Nationwide
31 Jan 2024Drug	CLASS II	Mesalamine Delayed-Release Tablets, USP per tablet recalledMesalamine	Sun Pharmaceutical Industries	Sterility	Nationwide
18 Nov 2020Drug	CLASS II	Mesalamine Delayed-Release Tablets recalled by Teva Pharmaceuticals UMesalamine	Teva Pharmaceuticals U	Potency & Assay	Nationwide
11 Mar 2020Drug	CLASS II	Mesalamine Delayed-Release Tablets recalled by Teva Pharmaceuticals UMesalamine	Teva Pharmaceuticals U	Potency & Assay	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.