FDA WARNING_LETTER - Medical Mega - November 03, 2025

On November 13, 2025, the FDA issued a Warning Letter to Medical Mega following a review of their website, medicalmega.com. The agency found the company was illegally marketing "Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan" in the United States. These products are classified as unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The FDA determined that these triclosan-containing consumer and healthcare antiseptic products are not generally recognized as safe and effective (GRASE), as established by FDA regulations (21 CFR part 330 and 21 CFR 310.545). Consequently, the products violate sections 505(a) and 301(d) of the FD&C Act, as no FDA-approved application is in effect for them. They are also misbranded under section 502(ee) and 301(a) of the FD&C Act for not complying with marketing requirements for nonprescription drugs subject to section 505G.

Medical Mega must respond in writing within 15 working days, detailing specific corrective actions to address these violations and prevent recurrence. Failure to comply may lead to further legal actions, including product seizure or injunction.