Nystatin 5bu recalls

The FDA has published 1 recall involving Nystatin 5bu since 2023. The latest was reported on 27 Dec 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 recalls1since 2023

Last 12 months0reported

Class I00% of total

Ongoing1latest 27 Dec 2023

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 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 1 100%Class III 0 0%

Why nystatin 5bu is recalled

Potency & Assay1100%

Companies

Fagron1100%

By year

20231100%

Ongoing nystatin 5bu recalls

1 active

Reported	Class	Recall	Company	Reason	Where
27 Dec 2023Drug	CLASS II	Nystatin 5BU, Activity (as is):/mg, bulk powder container recalled	Fagron	Potency & Assay	MN

All nystatin 5bu recalls, newest first

1 total

Reported	Class	Recall	Company	Reason	Where
27 Dec 2023Drug	CLASS II	Nystatin 5BU, Activity (as is):/mg, bulk powder container recalled	Fagron	Potency & Assay	MN

Should you stop taking Nystatin 5bu?

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.