Mesalamine recalls

The FDA has published 6 recalls involving Mesalamine since 2017. The latest was reported on 6 Mar 2024. Most were for potency & assay. Teva Pharmaceuticals 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 recalls6since 2017

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 5 83%Class III 1 17%

Why mesalamine is recalled

Companies

Brands

Mesalamine467%
Pentasa117%

By year

2024233%
2020350%
2017117%

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

6 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
18 Nov 2020Drug	CLASS II	Mesalamine Delayed-Release Tablets, USP (Once-Daily) recalled by AVKARE	AVKARE	Potency & Assay	Nationwide
11 Mar 2020Drug	CLASS II	Mesalamine Delayed-Release Tablets recalled by Teva Pharmaceuticals UMesalamine	Teva Pharmaceuticals U	Potency & Assay	Nationwide
25 Jan 2017Drug	CLASS III	Pentasa (mesalamine) Controlled-Release Capsules, 250 mg recalledPentasa	Shire	Other	Nationwide

Should you stop taking Mesalamine?

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.