FDA Cites Ketacyn Pharmaceuticals / www.ketacynpharma.com in June 23, 2026 Warning Letter — Unapproved New Drugs/Misbranded

FDA Warning Letter — Violations FDA cited at Ketacyn Pharmaceuticals / www.ketacynpharma.com

WARNING LETTER Ketacyn Pharmaceuticals / www.ketacynpharma.com MARCS-CMS 725153 — June 23, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED Product: Drugs Recipient: Ketacyn Pharmaceuticals / www.ketacynpharma.com United States info@ketacynpharma.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States June 23, 2026 WARNING LETTER Reference Number: MARCS-CMS 725153 To Ketacyn Pharmaceuticals: This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of your website www.ketacynpharma.com. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that you comply with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. As discussed below, FDA has observed that www.ketacynpharma.com introduces into interstate commerce unapproved and misbranded ketamine drug products, including certain drugs for which the FDA-approved version is an injectable or subject to a Risk Evaluation and Mitigation Strategy (REMS). 1 FDA has identified significant risks associated with unapproved ketamine products, especially in the absence of appropriate medical supervision. Given the increased interest in the use of ketamine products, the easy availability of unapproved and misbranded ketamine products via the internet puts U.S. consumers at risk for serious adverse events. Furthermore, injectable drug products can pose a serious risk of harm to users because they bypass many of the body's natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis. There are also inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Accordingly, FDA requests that www.ketacynpharma.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm. FDA Review Violations were identified and documented during a review of your website www.ketacynpharma.com, FDA Establishment Identifier (FEI) 3043544178, on February 26, 2026. Violations of the Federal Food, Drug, and Cosmetic Act On your website at internet address www.ketacynpharma.com, you introduce into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 502(f)(1), 503(b)(1), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 331(a), 331(d), 331(k), 352(f)(1), 353(b)(1), and 355(a)). The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations. Unapproved New Drug Violations Certain products offered for sale by www.ketacynpharma.com are drugs within the meaning of section 201(g) of the FD&C Act (21 U.S.C. 321(g)) because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act (21 U.S.C. 321(p))