Butoconazole recalls

The FDA has published 1 recall involving Butoconazole since 2023. The latest was reported on 8 Nov 2023. Most were for packaging defects. 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 8 Nov 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 butoconazole is recalled

Packaging Defects1100%

Companies

Padagis US1100%

By year

20231100%

Ongoing butoconazole recalls

1 active

Reported	Class	Recall	Company	Reason	Where
8 Nov 2023Drug	CLASS II	Gynazole-1, (Butoconazole Nitrate) Vaginal Cream recalled by Padagis USGynazole 1	Padagis US	Packaging Defects	Nationwide

All butoconazole recalls, newest first

1 total

Reported	Class	Recall	Company	Reason	Where
8 Nov 2023Drug	CLASS II	Gynazole-1, (Butoconazole Nitrate) Vaginal Cream recalled by Padagis USGynazole 1	Padagis US	Packaging Defects	Nationwide

Should you stop taking Butoconazole?

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.