FDA Notification Regarding Iodoquinol Drugs

On July 15, 2020, FDA announced the final decision of the Commissioner of Food and Drugs, that Vioform containing iodochlorhydroxyquin and hydrocortisone lacked substantial evidence, consisting of adequate and well-controlled studies, to be effective for specific indications. Vioform, containing iodochlorhydroxyquin and hydrocortisone, was part of the Drug Efficacy Study Implementation process.

FDA notified manufacturers and labelers of the products (listed below) on Oct. 30, 2024, to stop distributing their iodoquinol-containing drug products. As of Nov. 26, 2024, all the companies agreed to cease distribution of the unapproved iodoquinol drugs

FDA considers iodoquinol products unapproved new drugs that cannot be distributed in interstate commerce without a new drug application approved by FDA. The distribution of any unapproved iodoquinol drugs, not limited to the products listed below, is considered unlawful and subject to enforcement action.

Unapproved Iodoquinol Drugs

NDC	Product Name and Strength
52187-545	Hydrocortisone acetate 2% / Iodoquinol 1% / Aloe polysaccharides 1% gel
52187-532	Hydrocortisone 1% / Iodoquinol 1% cream
69367-286	Hydrocortisone 1% / Iodoquinol 1% cream
82429-119	Hydrocortisone acetate 2% / Iodoquinol 1% / Aloe polysaccharides 1% gel
52187-551	Hydrocortisone acetate 1.9% / Iodoquinol 1% cream
44118-704	Hydrocortisone acetate 1.9% / Iodoquinol 1% cream