FDA WARNING_LETTER - Great India Overseas Pvt. Ltd. dba Silkrute - May 01, 2026

In June 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to Great India Overseas Pvt. Ltd., operating as Silkrute, following a review of the company’s website in May 2026. The agency identified significant violations involving the sale of unapproved and misbranded drug products, including ProGlan Capsules, Cordiagra, and Prost Aid Tablet. According to the FDA, these products were marketed with claims to treat, cure, or prevent specific medical conditions—such as prostate issues, erectile dysfunction, and urinary tract infections—without the necessary federal approvals. Under the Federal Food, Drug, and Cosmetic Act, any product intended for such medical uses is classified as a drug and must be proven safe and effective through an FDA review process before being sold. Furthermore, ProGlan Capsules were found to be misbranded because their labeling featured the FDA logo and a false claim of being APPROVED, which misleadingly suggests government endorsement. The FDA warned that introducing these unapproved products into the U.S. market is a violation of federal law. To address these findings, Silkrute must investigate the root causes of the violations and implement corrective actions. The company is required to submit a written response within 15 business days detailing the steps taken to achieve compliance and prevent future recurrences. Failure to act may result in legal consequences, such as product seizures or injunctions.