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# FDA Warns Walmart, Amazon on Molluscum Drugs
- URL: https://www.fdaweb.com/fda-warns-walmart-amazon-on-molluscum-drugs/
- Published: 2023-08-22T12:00:00.000Z
- Updated: 2026-09-14T18:52:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155147

FDA says Amazon and Walmart are illegally distributing unapproved new drug products intended to treat molluscum contagiosum. The agency issued 8/18 Warning Letters to each company.

The Walmart [letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/walmart-inc-648620-08182023?ref=fdaweb.com) says the company’s Web site offers the Naturasil Molluscum Treatment Kit. FDA says it purchased the kit from the Web site, establishing that the company has introduced the drug into interstate commerce.

“Molluscum contagiosum is not a condition amenable to self-diagnosis and treatment,” the letter says, “and there are no legally marketed over-the-counter drug products to treat this condition…. The Naturasil Molluscum Treatment Kit is especially concerning from a public health perspective because it is marketed for use in children. In addition, FDA is concerned that people are forgoing or delaying proper diagnosis and treatment of a potentially serious, undiagnosed health condition by purchasing and using an unapproved drug product claiming to treat molluscum contagiosum.”

Walmart was told to respond with a list of specific steps it is taking to address the violations and prevent their recurrence, with documentation of the steps.

The Amazon [letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amazoncom-inc-649056-08182023?ref=fdaweb.com) says the company is distributing four unapproved new drugs that were purchased by FDA from its Web site to treat molluscum contagiosum: Naturasil Molluscum Treatment Kit, Conzerol 2 Step Treatment for Molluscum Contagiosum, ZymaDerm for Molluscum, and HealthyDerm Molluscum Contagiosum Treatment. FDA expressed the same concerns about the Amazon products that it did for the Walmart product.

Amazon was also told to respond with a list of specific steps it is taking to address the violations and prevent their recurrence, with documentation for each action taken.