FDA WARNING_LETTER - Ketacyn Pharmaceuticals / www.ketacynpharma.com - February 26, 2026

On June 23, 2026, the FDA issued a warning letter to Ketacyn Pharmaceuticals regarding the sale of unapproved and misbranded ketamine products through its website, www.ketacynpharma.com. An agency review conducted on February 26, 2026, found that the company introduced drug products, including "Ketamine Solution for Injection" and "Ketamine Gummies," into interstate commerce without required federal approvals. These activities violate several sections of the Federal Food, Drug, and Cosmetic Act. The FDA identified significant safety concerns, noting that these drugs were marketed without adequate instructions for safe use and were offered for sale without requiring a prescription from a licensed practitioner. Furthermore, the agency highlighted that injectable drugs and ketamine derivatives often require strict medical supervision and safety programs—known as Risk Evaluation and Mitigation Strategies—to prevent serious adverse events such as sedation, abuse, or life-threatening infections. Ketacyn Pharmaceuticals is required to immediately cease the sale of these unapproved products to U.S. consumers. The company must provide a written response to the FDA within 15 business days outlining specific corrective actions and a plan to prevent future violations. Failure to comply may result in legal actions, including product seizures or injunctions.