2026-08-04 FDA Warning Letter: Stokes Healthcare Inc. dba Epicur Pharma Cited for Animal Drugs/Adulterated
Letter issued · posted to fda.gov .
Subject as published: Animal Drugs/Adulterated
TL;DR
The short version: On August 4, 2026, the FDA's Center for Veterinary Medicine issued a warning letter to Stokes Healthcare Inc. dba Epicur Pharma (CEO Michael Tursi) regarding misbranded compounded animal drugs marketed on epicurpharma.com, including buprenorphine ER injection solution and omeprazole injection suspension. The FDA stated these unapproved/non-indexed drugs carry unsubstantiated claims of safety and effectiveness superior to FDA-approved or FDA-indexed alternatives, violating the Federal Food, Drug, and Cosmetic Act sections 502(a), 502(bb), and 201(n).
Argus analysis
# FDA Warning Letter Analysis: Stokes Healthcare Inc. dba Epicur Pharma
**Company and Findings**
The FDA's Center for Veterinary Medicine issued a warning letter to Stokes Healthcare Inc., operating as Epicur Pharma, on August 4, 2026. The company markets compounded animal drugs through its website, including buprenorphine ER injection solution and omeprazole injection suspension. FDA reviewers found that promotional claims about these products violated the Federal Food, Drug, and Cosmetic Act by misrepresenting safety, effectiveness, and regulatory status. The letter was addressed to CEO Michael Tursi at the company's Mount Laurel, New Jersey headquarters.
**Regulatory Citations and Context**
The FDA cited sections 502(a), 502(bb), and 201(n) of the FD&C Act (21 U.S.C. §§ 352(a), 352(bb), and 321(n)), which address misbranded drugs—products with false, misleading, or inadequate labeling. Epicur's omeprazole claims misrepresented superiority over FDA-approved alternatives like GastroGard and Gastrobim, citing studies that did not support the assertions. The buprenorphine marketing called the product "gold standard" while falsely claiming FDA indexing was underway and misrepresenting shelf life of the approved competitor ETHIQA XR. Additionally, the company falsely claimed compliance with FDA Guidance for Industry #256 and suggested section 503B (human drug outsourcing) exemptions apply to animal drugs, which they do not.
**Next Steps and Industry Monitoring**
Companies in animal pharmaceutical compliance should expect a response deadline, typically 15 business days, requiring corrective action and substantiation. Peers should monitor whether Epicur removes misleading claims, ceases comparative statements without adequate data, and clarifies that compounded products lack FDA approval or indexing. The warning letter signals FDA's continued scrutiny of compounded animal drug marketing, particularly regarding unsubstantiated superiority claims and misrepresentation of regulatory pathways.
Severity context
Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
Regulatory background
FDA Warning Letters are administratively non-binding but signal that recurring non-compliance may escalate to injunction, seizure, import alert, or Application Integrity Policy invocation.
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
WARNING LETTER Stokes Healthcare Inc. dba Epicur Pharma MARCS-CMS 733243 — August 04, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Animal & Veterinary Drugs Recipient: Recipient Name Michael Tursi Recipient Title CEO Stokes Healthcare Inc. dba Epicur Pharma 8000 Commerce Parkway, Ste. 600 Mount Laurel , NJ 08054 United States mtursi@stokespharmacy.com Issuing Office: Center for Veterinary Medicine United States WARNING LETTER August 4, 2026 Re: 733243 Dear Michael Tursi: This letter is to advise you that the United States Food and Drug Administration (FDA) has reviewed your website https://epicurpharma.com, where you market various compounded animal drugs in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). As explained further below, the claims on your website concerning your compounded animal drugs, including buprenorphine ER injection solution and omeprazole injection suspension, are false or misleading and the drugs are therefore misbranded under sections 502(a), 502(bb), and 201(n) of the FD&C Act (21 U.S.C. §§ 352(a), 352(bb) and 321(n)). Your statements create a false or misleading impression about the safety and effectiveness of your compounded drugs, which are not FDA-approved or indexed. By encouraging use of these treatments instead of drugs that have been through FDA approval or indexing, you expose patients to unknown risks, including the risk of ineffective treatment. Unsubstantiated Claims Your compounded drugs are not FDA-approved, conditionally approved, or index listed. 1 Animal drugs produced in human drug outsourcing facilities, registered under section 503B of the Act, are not exempt from the FD&C Act’s requirements for adequate directions for use or approval. 2 Unless a drug is compounded using FDA-approved drugs (i.e., using the approved drug as the source of active ingredients) in compliance with 21 CFR Part 530, it violates the FD&C Act because it is not approved or indexed, and cannot satisfy the FD&C Act’s adequate directions for use provision (which requires, among other things, that a prescription drug have an FDA-approved labeling). 3 Promotional materials misbrand a drug if they contain false or misleading comparisons that represent or suggest that it is safer or more effective than another drug when this has not been demonstrated. You make such claims for the following products: Compounded Omeprazole Injection Suspension Omeprazole is the active ingredient in multiple, FDA approved animal drugs, including GastroGard (NADA 141-123), UlcerGard (NADA 141-227), and Gastrobim (ANADA 200-842). The following are examples of claims made through your website, epicurpharma.com, where you state or imply your unapproved drugs are safe, effective, comparable, and/or superior to FDA-approved drugs: “Changing the game for equine gastric ulcers.” “…an innovative alternative for equine gastric ulcers” “…Epicur is bringing the same unique, proven fo…
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- Has Stokes Healthcare Inc. dba Epicur Pharma had FDA enforcement actions before?
- Yes. Argus HQ has recorded 2 total FDA actions tied to Stokes Healthcare Inc. dba Epicur Pharma: 1 warning letter, 0 recalls, and 0 approval records.
- What FDA violations was Stokes Healthcare Inc. dba Epicur Pharma cited for?
- The FDA Warning Letter to Stokes Healthcare Inc. dba Epicur Pharma (issuing office: Center for Veterinary Medicine) cites: Animal Drugs/Adulterated. Classification: Warning Letter.
- When did FDA issue the warning letter to Stokes Healthcare Inc. dba Epicur Pharma?
- FDA issued the letter (MARCS-CMS 733243) on 2026-08-04 and posted it publicly on fda.gov on 2026-09-29.
- Is the FDA warning letter to Stokes Healthcare Inc. dba Epicur Pharma publicly available?
- Yes. The full verbatim letter is published at fda.gov. Argus HQ links directly to the source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stokes-healthcare-inc-dba-epicur-pharma-733243-08042026.
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). 2026-08-04 FDA Warning Letter: Stokes Healthcare Inc. dba Epicur Pharma Cited for Animal Drugs/Adulterated. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-stokes-healthcare-inc-dba-epicur-pharma-2026-08-04-warning-letter
"2026-08-04 FDA Warning Letter: Stokes Healthcare Inc. dba Epicur Pharma Cited for Animal Drugs/Adulterated." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-stokes-healthcare-inc-dba-epicur-pharma-2026-08-04-warning-letter.
Argus HQ Research. "2026-08-04 FDA Warning Letter: Stokes Healthcare Inc. dba Epicur Pharma Cited for Animal Drugs/Adulterated." Digital Empire Holdings LLC. Accessed September 30, 2026. https://argushq.ai/fda/warning-letter/fda-wl-stokes-healthcare-inc-dba-epicur-pharma-2026-08-04-warning-letter.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_stokes_healthcare_inc_dba_epicur_pharma_2026_08_04_warning_letter_2026,
title = {2026-08-04 FDA Warning Letter: Stokes Healthcare Inc. dba Epicur Pharma Cited for Animal Drugs/Adulterated},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-stokes-healthcare-inc-dba-epicur-pharma-2026-08-04-warning-letter},
note = {Accessed: September 30, 2026}
}