FDA WARNING_LETTER - Extra Medication / www.extramedication.com - March 02, 2026

On June 23, 2026, the FDA issued a warning letter to Extra Medication (operating through www.extramedication.com) following a website review conducted on March 2, 2026. The agency identified significant violations of the Federal Food, Drug, and Cosmetic Act, specifically concerning the sale of unapproved and misbranded ketamine products marketed under names such as "Calypsol" and "ketanest." The FDA found that the company was distributing these substances without approved drug applications, bypassing critical safety and effectiveness evaluations. The products are considered misbranded because they lack adequate directions for safe use and are being sold without required prescriptions from licensed healthcare providers. The letter highlights the severe risks associated with unsupervised ketamine use, including respiratory depression, sedation, and potential abuse. Furthermore, the sale of injectable drugs poses a high risk of life-threatening infections like sepsis. The company is required to immediately cease the sale of these unapproved medications to U.S. consumers. Extra Medication must provide a written response to the FDA within 15 business days detailing the corrective actions taken and the measures implemented to prevent future violations. Failure to comply may result in regulatory actions, such as product seizures or legal injunctions.