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Darifenacin recalls

Darifenacin products have been recalled 2 times, most recently on 2 Jun 2021. The recalling company is usually Cardinal Health. The most common reason is manufacturing (cgmp) deviations.

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 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

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.