June 17, 2026 FDA Warning Letter: Texinkart Inc. Cited for Unapproved New Drugs/Misbranded

FDA Warning Letter — Violations FDA cited at Texinkart Inc.

WARNING LETTER Texinkart Inc. MARCS-CMS 729046 — June 17, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Drugs Recipient: Texinkart Inc. 2055 Limestone Road Wilmington , DE 19808 United States hello@texinkart.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States June 17, 2026 WARNING LETTER Reference Number: 729046 To Texinkart Inc.: This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website. 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 your firm complies 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. FDA Review Violations were identified and documented during a review of your website https://texinkart.com/ in April 2026. Based on our review, “Thathu Busti Lehyam,” “Baidyanath Prostaid Tablets,” “Rajpro Capsules,” and “Rathina Purush Capsules” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). Violations of the Federal Food, Drug, and Cosmetic Act The following are violations identified during our review. As a reminder, this is not an allinclusive list of violations that may exist in connection with your products or operations. Unapproved New Drug Violations Based on a review of your website, “Thathu Busti Lehyam,” “Baidyanath Prostaid Tablets,” “Rajpro Capsules,” and “Rathina Purush Capsules” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following: Thathu Busti Lehyam On the webpage https://texinkart.com/products/dhathubushti-lehyam-250gm: “Indications: . . . o Spermatorrhoea [sic] o Erectile dysfunction” Baidyanath Prostaid Tablets On the webpage https://texinkart.com/products/baidyanath-prostaid-tablets-60-tablets: “Baidyanath (Jhansi) Prostaid Tablet is an ayurvedic formulation that can help in dealing with prostate gland enlargement.” Rajpro Capsules On the webpage https://texinkart.com/products/rajpro-capsules-60capsules: “Energy, Vigour [sic] & Vitality” “Substantially Increases your Sexual Desire and Stamina” Rathina Purush Capsules On the webpage https://texinkart.com/products/skm-rathina-purush-capsules-10capsules: “Description: o Strengthens the sperm o Increases the sexual strength . . . o Increases the semen concentration” “Thathu Busti Lehyam,” “Baidyanath Prostaid Tablets,” “Rajpro Capsules,” and “Rathina Purush Capsules” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to se