FDA WARNING_LETTER - Texinkart Inc. - April 01, 2026

On June 17, 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to Texinkart Inc. following a regulatory review of the company’s website conducted in April 2026. The FDA determined that Texinkart is marketing several products, including ‘Thathu Busti Lehyam,’ ‘Baidyanath Prostaid Tablets,’ ‘Rajpro Capsules,’ and ‘Rathina Purush Capsules,’ as treatments for medical conditions such as prostate enlargement, erectile dysfunction, and other health issues. Under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, products intended to diagnose, cure, mitigate, or treat diseases are classified as drugs. Because these specific products lack formal FDA approval and are not generally recognized as safe and effective for their advertised uses, they are legally classified as unapproved new drugs. Selling these products in interstate commerce constitutes a violation of federal law. The FDA has mandated that Texinkart Inc. immediately correct these violations and implement long-term preventative measures. The company is required to submit a written response within 15 business days detailing the specific actions taken to ensure compliance and provide supporting documentation. Failure to address these issues promptly may result in further legal action, such as product seizures or injunctions.