Itraconazole recalls

The FDA has published 4 recalls involving Itraconazole since 2014. The latest was reported on 21 Apr 2021. Most were for sterility. Well Care Compounding Pharmacy 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 recalls4since 2014

Last 12 months0reported

Class I00% of total

Ongoing0latest 21 Apr 2021

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 itraconazole is recalled

Companies

By year

2021125%
2016250%
2014125%

All itraconazole recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
21 Apr 2021Drug	CLASS II	Itraconazole Capsules, 100 mg recalled by Jubilant Cadista	Jubilant Cadista Pharmaceuticals	Potency & Assay	Nationwide
15 Jun 2016Drug	CLASS II	Itraconazole 0.2%/mupirocin 0.2%/triamcinolone 0.03% Nasal Spray recalled	Well Care Compounding Pharmacy	Sterility	NV
15 Jun 2016Drug	CLASS II	Itraconazole 0.2%/mupirocin 0.2% Nasal Spray recalled	Well Care Compounding Pharmacy	Sterility	NV
22 Jan 2014Drug	CLASS II	Itraconazole, Capsule, 100 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states

Should you stop taking Itraconazole?

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.