Great India Overseas Pvt. Ltd. dba Silkrute — FDA Warning Letter, June 17, 2026: Unapproved New Drugs

FDA Warning Letter — Violations FDA cited at Great India Overseas Pvt. Ltd. dba Silkrute

WARNING LETTER Great India Overseas Pvt. Ltd. dba Silkrute MARCS-CMS 729065 — June 17, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED Product: Drugs Recipient: Recipient Name Mohit Singla Recipient Title Chief Executive Officer Great India Overseas Pvt. Ltd. dba Silkrute #72 Sahni Complex, Model Town Yamunanagar 135001 Haryana India Support@silkrute.com admin@silkrute.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States June 17, 2026 3993 Hanover Street New York, NY 10016 WARNING LETTER Reference Number: 729065 To Mohit Singla: 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://www.silkrute.com in May 2026. Based on our review, “ProGlan Capsules,” “Cordiagra,” and “Prost Aid Tablet” are unapproved new drugs under sections 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). Furthermore, “ProGlan Capsules” is a misbranded drug under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(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 all-inclusive list of violations that may exist in connection with your products or operations. Unapproved New Drug Violations Based on a review of your website, “ProGlan Capsules,” “Cordiagra,” and “Prost Aid Tablet” products 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: ProGlan Capsules On the webpage https://www.silkrute.com/health-and-personal/diet-and-nutrition/supplement/crd-ayurveda-proglan-prostate-gland-capsules-50-capsules: “Useful in problems of Prostate Glands . . . improves immune system and improves overall muscle strength. ProGlan capsules help in maintaining urinary health. These supplements are good for keeping prostate health in check by combining the best and most natural ingredients.” Cordiagra On the webpage https://www.silkrute.com/health-and-personal/diet-and-nutrition/supplement/cordy-herb-cordiagra-stamina-and-energy-booster-mens-sexual-wellness-capsule-for-erectile-dysfunction-with-cordyceps-honey-goat-weed-tongat-ali-maca-root-ginseng-ashwagandha-10capsule: “Increase Your Sexual Drive, Strength & Stamina.” “For Sexual Dysfunction” “FOR ERECTILE DYSFUNCTION” Prost Aid Tablet On the webpage https://www.silkrute.com/health-and-personal/diet-and-nutrition/supplement/baidyanath-prostaid-i-urinary-track-infection-i-50-tablets: “[A]lleviates