FDA WARNING_LETTER - Stokes Healthcare, Inc. dba Epicur Pharma - August 03, 2026

On August 4, 2026, the FDA issued a warning letter to Stokes Healthcare Inc., doing business as Epicur Pharma, following a review of the company’s website. The agency determined that Epicur Pharma is marketing compounded animal drugs, including buprenorphine ER and omeprazole injections, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The primary violations involve misbranding through false and misleading claims that suggest these unapproved products are safer, more effective, or superior to FDA-approved and indexed drugs. Specifically, the FDA noted that Epicur Pharma cited studies that did not support its clinical claims and falsely stated that "FDA indexing" was underway for certain products. Furthermore, the company failed to communicate essential safety risks, such as the potential for human abuse and addiction associated with buprenorphine. The letter also clarifies that Epicur Pharma misrepresented its regulatory status by incorrectly claiming compliance with Guidance for Industry (GFI) #256 and falsely suggesting that exemptions for human drug outsourcing facilities (Section 503B) apply to animal drugs. To address these issues, Epicur Pharma must submit a written response within 15 working days outlining the corrective actions taken to resolve the violations and prevent their recurrence. Failure to comply may lead to legal action, including product seizures or injunctions.