Fesoterodine recalls

The FDA has published 2 recalls involving Fesoterodine since 2025. The latest was reported on 14 Jan 2026. Most were for potency & assay. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls2since 2025

Last 12 months2reported

Class I00% of total

Ongoing2latest 14 Jan 2026

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 1 0 1Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 0 0%Class III 2 100%

Why fesoterodine is recalled

Potency & Assay2100%

Companies

Alembic Pharmaceuticals2100%

By year

2026150%
2025150%

Ongoing fesoterodine recalls

2 active

Reported	Class	Recall	Company	Reason	Where
14 Jan 2026Drug	CLASS III	Fesoterodine Fumarate, Extended-release Tablets, 8 mg recalledFesoterodine Fumarate	Alembic Pharmaceuticals	Potency & Assay	Nationwide
26 Nov 2025Drug	CLASS III	Fesoterodine Fumarate, Extended-release Tablets, 4 mg recalledFesoterodine Fumarate	Alembic Pharmaceuticals	Potency & Assay	Nationwide

All fesoterodine recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
14 Jan 2026Drug	CLASS III	Fesoterodine Fumarate, Extended-release Tablets, 8 mg recalledFesoterodine Fumarate	Alembic Pharmaceuticals	Potency & Assay	Nationwide
26 Nov 2025Drug	CLASS III	Fesoterodine Fumarate, Extended-release Tablets, 4 mg recalledFesoterodine Fumarate	Alembic Pharmaceuticals	Potency & Assay	Nationwide

Should you stop taking Fesoterodine?

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.