Mirabegron recalls

The FDA has published 1 recall involving Mirabegron since 2026. The latest was reported on 12 Aug 2026. Most were for nitrosamine impurity. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls1since 2026

Last 12 months1reported

Class I00% of total

Ongoing1latest 12 Aug 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 1Aug 0 0

Severity split

Class I 0 0%Class II 1 100%Class III 0 0%

Why mirabegron is recalled

Nitrosamine Impurity1100%

Companies

Zydus Pharmaceuticals1100%

By year

20261100%

Ongoing mirabegron recalls

1 active

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Drug	CLASS II	Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide

All mirabegron recalls, newest first

1 total

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Drug	CLASS II	Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide

Should you stop taking Mirabegron?

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.