Solifenacin recalls

The FDA has published 6 recalls involving Solifenacin since 2014. The latest was reported on 16 Apr 2025. Most were for manufacturing (cgmp) deviations. Glenmark Pharmaceuticals Inc., USA 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 2014

Last 12 months0reported

Class I00% of total

Ongoing2latest 16 Apr 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 2 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 6 100%Class III 0 0%

Why solifenacin is recalled

Manufacturing (CGMP) Deviations583%
Labeling Errors117%

Companies

By year

2025233%
2021117%
2020233%
2014117%

Ongoing solifenacin recalls

2 active

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Solifenacin Succinate Tablets 10MG, a. bottle recalledSolifenacin Succinate	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Solifenacin Succinate Tablets 5mg, a.) bottle recalledSolifenacin Succinate	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide

All solifenacin recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Solifenacin Succinate Tablets 10MG, a. bottle recalledSolifenacin Succinate	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Solifenacin Succinate Tablets 5mg, a.) bottle recalledSolifenacin Succinate	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
21 Jul 2021Drug	CLASS II	Solifenacin Succinate Tablets, 10 mg recalled by CIPLA	Cipla	Manufacturing (CGMP) Deviations	Nationwide
25 Mar 2020Drug	CLASS II	Solifenacin Succinate Tablets, 5mg recalled	Breckenridge Pharmaceutical	Manufacturing (CGMP) Deviations	Nationwide
25 Mar 2020Drug	CLASS II	Solifenacin Succinate Tablets, 10 mg recalled	Breckenridge Pharmaceutical	Manufacturing (CGMP) Deviations	Nationwide
22 Jan 2014Drug	CLASS II	Solifenacin Succinate Tablet, 5 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states

Should you stop taking Solifenacin?

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.