Darifenacin recalls

The FDA has published 2 recalls involving Darifenacin since 2021. The latest was reported on 2 Jun 2021. Most were for manufacturing (cgmp) deviations. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls2since 2021

Last 12 months0reported

Class I00% of total

Ongoing0latest 2 Jun 2021

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 2 100%Class III 0 0%

Why darifenacin is recalled

Manufacturing (CGMP) Deviations2100%

Companies

Cardinal Health2100%

By year

20212100%

All darifenacin recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
2 Jun 2021Drug	CLASS II	Darifenacin Extended-release Tablets 7.5 mg recalled by Cardinal HealthDarifenacin	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
2 Jun 2021Drug	CLASS II	Darifenacin Extended-release Tablets 15 mg recalled by Cardinal HealthDarifenacin	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC

Should you stop taking Darifenacin?

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.