Oxybutynin recalls

The FDA has published 4 recalls involving Oxybutynin since 2023. The latest was reported on 15 Nov 2023. 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 recalls4since 2023

Last 12 months0reported

Class I00% of total

Ongoing0latest 15 Nov 2023

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 4 100%Class III 0 0%

Why oxybutynin is recalled

Potency & Assay4100%

Companies

Zydus Pharmaceuticals (USA)4100%

By year

20234100%

All oxybutynin recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
15 Nov 2023Drug	CLASS II	Oxybutynin Chloride Extended-Release Tablet USP, 10 mg recalledOxybutynin	Zydus Pharmaceuticals (USA)	Potency & Assay	Nationwide
15 Nov 2023Drug	CLASS II	Oxybutynin Chloride Extended-Release Tablet USP, 15 mg recalledOxybutynin	Zydus Pharmaceuticals (USA)	Potency & Assay	Nationwide
15 Nov 2023Drug	CLASS II	Oxybutynin Chloride Extended-Release Tablet USP, 5 mg recalledOxybutynin	Zydus Pharmaceuticals (USA)	Potency & Assay	Nationwide
11 Oct 2023Drug	CLASS II	Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) recalledOxybutynin	Zydus Pharmaceuticals (USA)	Potency & Assay	Nationwide

Should you stop taking Oxybutynin?

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.