Calibrate IV Hydration – FDA Warning Letter, Oct 1, 2026

On October 13, 2026, the FDA issued a warning letter to Calibrate IV Hydration following a review of the company’s website in October 2026. The agency determined that the company is marketing umbilical cord-derived and exosome products for various medical conditions without the necessary federal approvals. According to the FDA, these products are promoted for treating complex issues related to neurology, immunology, orthopedics, and endocrinology, which classifies them as unapproved new drugs and unlicensed biological products. Under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, such products require a valid license to prove they are safe, pure, and potent before being sold. The FDA specifically noted that these products do not qualify for streamlined regulation as human tissues because they are not being used for their original biological functions. Calibrate IV Hydration was warned that selling these products violates federal law and could lead to legal action, such as product seizures or court-ordered shutdowns. The company is required to provide a written response within 15 working days detailing the specific steps taken to correct these violations and ensure future compliance.