Donepezil recalls

The FDA has published 5 recalls involving Donepezil since 2017. The latest was reported on 3 Jan 2024. Most were for potency & assay. Cardinal Healthcare 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 recalls5since 2017

Last 12 months0reported

Class I00% of total

Ongoing0latest 3 Jan 2024

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 40%Class III 3 60%

Why donepezil is recalled

Potency & Assay360%
Manufacturing (CGMP) Deviations240%

Companies

By year

2024240%
2021120%
2017240%

All donepezil recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
3 Jan 2024Drug	CLASS II	Donepezil HCl Tablets, 10 mg recalled by Cardinal HealthcareDonepezil Hydrochloride	Cardinal Healthcare	Manufacturing (CGMP) Deviations	Nationwide
3 Jan 2024Drug	CLASS II	Donepezil HCl Tablets, 5 mg recalled by Cardinal HealthcareDonepezil Hydrochloride	Cardinal Healthcare	Manufacturing (CGMP) Deviations	Nationwide
8 Sep 2021Drug	CLASS III	Donepezil HCL Tablets, USP, 5 mg recalled by Jubilant Cadista	Jubilant Cadista Pharmaceuticals	Potency & Assay	Nationwide
3 May 2017Drug	CLASS III	Donepezil HCl tablets, 10mg recalled by Mckesson Packaging Services	Mckesson Packaging Services	Potency & Assay	CO, LA, OH
25 Jan 2017Drug	CLASS III	Donepezil Hydrochloride Tablets, 10 mg recalled by Sandoz	Sandoz	Potency & Assay	Nationwide

Should you stop taking Donepezil?

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.