Warning Letter — Ketamine Troche Store / www.ketaminetrochestore.com
The FDA issued a warning letter to Ketamine Troche Store (www.ketaminetrochestore.com) for the sale of potentially unapproved or misbranded drug products.
This affects the operators of the Ketamine Troche Store website and similar online entities involved in the distribution of ketamine-based products.
This enforcement action by CDER suggests continued scrutiny of online platforms distributing ketamine outside of standard regulatory pathways. Regulatory teams should interpret this as a signal that the FDA is actively monitoring digital storefronts for compliance with drug approval and labeling requirements, particularly for substances with high potential for misuse or specialized administration routes.
Review online product listings and marketing claims to ensure they do not bypass prescription requirements or make unauthorized therapeutic claims. Ensure all distribution channels for controlled substances or specialized dosage forms comply with federal registration and approval requirements.
FDA Warning Letter issued to: Ketamine Troche Store / www.ketaminetrochestore.com. 06/23/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ketamine-troche-store-wwwketaminetrochestorecom-722122-06232026
Open in openFDA / FDA.gov