Dicopanol (diphenhydramine recalls

The FDA has published 1 recall involving Dicopanol (diphenhydramine since 2015. The latest was reported on 18 Mar 2015. Most were for sterility. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls1since 2015

Last 12 months0reported

Class I00% of total

Ongoing0latest 18 Mar 2015

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 1 100%Class III 0 0%

Why dicopanol (diphenhydramine is recalled

Sterility1100%

Companies

Fusion Pharmaceuticals1100%

By year

20151100%

All dicopanol (diphenhydramine recalls, newest first

1 total

Reported	Class	Recall	Company	Reason	Where
18 Mar 2015Drug	CLASS II	Dicopanol (diphenhydramine hydrochloride recalled	Fusion Pharmaceuticals	Sterility	CA

Should you stop taking Dicopanol (diphenhydramine?

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.