FDA WARNING_LETTER - Revlon Group Holdings, LLC - September 01, 2025

The FDA issued a warning letter on June 2, 2026, to Revlon Group Holdings, LLC, following a review of manufacturing records requested in September 2025 for its Oxford, North Carolina facility. The agency found significant violations of Current Good Manufacturing Practice (CGMP) regulations, rendering the company’s over-the-counter (OTC) drug products adulterated under the Federal Food, Drug, and Cosmetic Act. A primary concern is the company"s failure to adequately test talc components for asbestos, a known carcinogen. Revlon relied on supplier testing without verifying those results and failed to perform complete identity testing as required by the United States Pharmacopeia (USP). Additionally, the company"s Quality Control Unit failed to maintain proper oversight, allowing the use of ingredients with deficient specifications and high microbiological counts. The FDA also noted a pattern of distributing drug products very close to their expiration dates. To achieve compliance, Revlon must conduct a comprehensive risk assessment of all talc-containing products, perform immediate asbestos testing on retained samples, and provide a detailed plan to reformulate products to eliminate talc. Furthermore, the company is required to remediate its Quality Control Unit and align all testing procedures with current USP standards.