FDA WARNING_LETTER - Ketamine Troche Store / www.ketaminetrochestore.com - January 16, 2026

On June 23, 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to Ketamine Troche Store (www.ketaminetrochestore.com) following a review of the company’s website conducted from January 9 to January 16, 2026. The FDA identified significant violations of the Federal Food, Drug, and Cosmetic Act, specifically regarding the sale of unapproved and misbranded ketamine drug products. The company offered various forms of the drug, including "Ketamine Liquid," "Ketamine Suppository," "Ketamine Nasal Spray," and "Ketamine 100 mg Troche," for conditions such as depression and chronic pain. The FDA highlighted that these products lack the necessary safety and effectiveness approvals required for new drugs. Furthermore, the agency noted that the products were sold without requiring a prescription from a licensed healthcare provider, which misbrands the items and poses a severe risk to public safety. The company also failed to meet the legal requirements for compounding exemptions, as they did not require individual patient prescriptions and were not operating as a registered outsourcing facility. To address these issues, the FDA requires Ketamine Troche Store to immediately cease the sale of these illegal products and provide a written response within 15 business days. This response must detail the corrective actions taken to resolve the violations and the steps implemented to prevent their recurrence. Failure to comply may result in legal action, including product seizure or injunctions.