All Ketamine HCL / www.allketaminehcl.com – FDA Warning Letter, Feb 27, 2026

On June 23, 2026, the FDA issued a warning letter to All Ketamine HCL regarding the sale of unapproved and misbranded drug products through their website, www.allketaminehcl.com. This action follows a regulatory review conducted on February 27, 2026, which found that the company was introducing unauthorized medications, such as "Ketamax," into U.S. commerce. Under the Federal Food, Drug, and Cosmetic Act, medications like ketamine are strictly regulated as controlled substances and typically require a prescription and professional medical supervision. The FDA identified several critical issues, including the distribution of drugs without approved applications and the lack of adequate directions for safe use. Because the company offers prescription-strength injectable drugs without requiring a doctor’s oversight, they bypass essential safety safeguards, putting consumers at risk of severe adverse events, including life-threatening infections and drug abuse. Furthermore, these products lack the safety and quality assurances provided by the FDA approval process. To address these violations, All Ketamine HCL must immediately cease the sale of these unapproved products to U.S. consumers. The company is required to submit a written response within 15 business days outlining the specific corrective actions taken to resolve the current violations and the measures implemented to prevent future recurrences. Continued non-compliance may lead to legal action, including the seizure of products or court-ordered injunctions.