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  5. Stokes Healthcare Inc. dba Epicur Pharma - 733243 - 08/04/2026
  1. Warning Letters

WARNING LETTER

Stokes Healthcare Inc. dba Epicur Pharma MARCS-CMS 733243 —

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 formulation of omeprazole injection to the U.S. for the treatment of equine gastric ulcers.”
  • “Benefits of this formulation over the traditional oral paste include: …
    o More rapid healing with [Equine Squamous Gastric Disease (ESGD)] healing in 10 days and [Equine Glandular Gastric Disease (EGGD)] in 20 days with the injection, compared to the traditional month of treatment with oral treatment (Sundra T, Kelty E, Rendle D, 2024)”

Compounded drug products are not FDA-approved or indexed. The claims on your website misleadingly suggest that your compounded omeprazole injection suspension is comparable or superior to FDA-approved omeprazole drugs. FDA-approved drugs have been reviewed to ensure they are safe and effective. Neither the safety nor the effectiveness of your product has been reviewed by FDA. Additionally, the literature cited does not appear to support the statement listed above because the study did not review treatment at 10 days, did not find a significant result for ESGD, and did not review records for horses treated with oral omeprazole drugs. The study by Sundra et al. 2024 reviewed the veterinary records of horses that had received four doses of an injectable omeprazole drug at either 5-day or 7-day dosing intervals. The study compared effectiveness of the two dosing intervals using gastroscopy images collected 5 to 7 days after the fourth dose. The study concluded that 5-day intervals resulted in more horses with EGGD healing compared with 7-day intervals, but did not find a significant difference for ESGD healing. The study did not review records for horses that received oral omeprazole drugs or compare the effectiveness of 5-day vs. 7-day dosing intervals for the oral omeprazole drugs. As a result, these claims are false or misleading and your product is therefore misbranded under sections 502(a), 502(bb) and 201(n) of the FD&C Act.

Compounded Buprenorphine ER Injection Solution

Buprenorphine is the active ingredient in three drugs on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, including one marketed drug, ETHIQA XR (MIF 900-014). The following are examples of claims on your website, epicurpharma.com, where you state or imply your unapproved drugs are safe, effective, comparable and/or superior to legally marketed indexed drugs:

  • “Next-Generation Buprenorphine Analgesia for Rats and Mice”
  • “Meet the new gold standard in lab animal pain relief”

Comparisons are made between your buprenorphine ER injection solution and “Buprenorphine ER Alternatives” as shown in the table below.

Stokes WL

The claims on your website misleadingly suggest that your compounded buprenorphine ER injection solution is comparable or superior to FDA-indexed drugs. FDA-indexed drugs have had their safety and effectiveness affirmed through an alternative FDA review process. Neither the safety nor the effectiveness of your compounded product has been reviewed by FDA.

Furthermore, your claim that “FDA indexing [is] underway” is false or misleading because it implies that you have started the indexing process by submitting information to FDA that is under review by FDA.4 (b)(4). However, as of the date of this letter, you have not opened a file or submitted information to FDA for review for indexing, so “FDA indexing” is not currently underway.

You state that the FDA-indexed buprenorphine ER alternative has a 2-month shelf life. This is false. Ethiqa XR™ is a buprenorphine extended-release injectable suspension that is FDA-indexed and is currently marketed. Ethiqa has a 36-month shelf life and its label states “once broached, the multi-dose vial should be discarded after 90 days”.

False or Misleading Risk Presentation

Promotional materials misbrand a drug if they are false or misleading with respect to risk. Among other reasons, promotional material can be misleading due to the representations it makes or suggests.5 It can also be misleading if it fails to reveal facts that are material when viewed in light of the representations made, including facts related to the potential consequences (e.g., adverse effects) of using the drug either as suggested in the promotion or under the usual conditions of use.

The promotional materials for your compounded buprenorphine ER injection solution fail to communicate risk information associated with the product. This is particularly concerning in light of the known risks associated with buprenorphine as explained in the product labeling of the drugs approved and indexed by the FDA that contain buprenorphine. Buprenorphine is classified as a Schedule III narcotic due to human abuse and addiction potential and poses severe human exposure risks, including accidental skin absorption or ingestion dangers. Additionally, your promotional materials for the omeprazole injection suspension drug product do not sufficiently communicate risk information associated with the use of the drug.

False and/or Misleading Advertising about the FDA and the Legality of Compounded Animal Drugs

False or Misleading Advertising Regarding FDA’s Animal Drug Compounding Guidance

Your website states that your buprenorphine ER injection solution is “Compliant with GFI #256” and available for office use. This statement is false. Buprenorphine injectable polymeric matrix solution for use in rodents (e.g., mice and rats) is on the list of Bulk Drug Substances Reviewed and Not Listed. Therefore, buprenorphine ER injection solution compounded for use as office stock in rats and mice is not consistent with the recommendations in GFI #256, and your assertion otherwise is false or misleading.

False or Misleading Advertising About FDA’s Oversight of Compounded Drugs

On your website, you make the following claim about all of your compounded tablets:

  • “…All Epicur® tablets are manufactured to FDA specifications”
    This statement is false or misleading because FDA does not review, set, or approve specifications for compounded drugs.

False or Misleading Advertising About the Legality of Compounded Animal Drugs

On your website, you make the following claims about the legal status of animal drugs (including your drugs) compounded in a human drug outsourcing facility:

  • “Available for dispensing and unlimited hospital administration FDA Federal SEC. 503B. [21 U.S.C. 353b]”

This statement suggests that the animal drugs listed on the page are legal for dispensing as office stock under FD&C Act section 503B, which is false, because the exemptions in section 503B do not apply to animal drugs.

  • “…Buprenorphine Injection is on the do not compound List for office use under GFI #256 which means you must order compounded Buprenorphine from a 503B like Epicur! Stay FDA & DEA compliant…”

This statement suggests Buprenorphine Injection is legal for dispensing as office stock if produced in a 503B human drug outsourcing facility, which is false because the exemptions in section 503B do not apply to animal drugs.

Conclusion

This letter notifies you of our concerns and provides you with an opportunity to address them. Failure to address this matter may lead to legal action without further notice, including, without limitation, seizure and injunction.

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA’s implementing regulations.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

Please direct your response to U.S. Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Drug Compliance by email to CVMUnapprovedDrugs@fda.hhs.gov.

Sincerely,
/S/

Johnetta Walters, Ph.D.
Acting Division Director
Division of Drug Compliance
Office of Surveillance and Compliance
Center for Veterinary Medicine
U.S. Food & Drug Administration

________________________

1 Sections 512, 571, and 572 of the FD&C Act (21 U.S.C. §§ 360b, 360ccc, 360ccc-1).

2 Section 503B(a) of the FD&C Act exempts human drugs from the new drug approval requirements of section 505, but section 503B(a) (21 U.S.C. § 353b) omits any reference to the new animal drug approval requirements in section 512 of the FD&C Act. The exemptions in section 503B apply only to human drugs.

3 FD&C Act sections 512(a) and 502(f) (21 U.S.C. §§ 360b(a), 352(f)).

4 See FD&C Act section 572(c) (21 U.S.C. § 360ccc-1(c)).

5 See FD&C Act section 201(n), 21 U.S.C. 321(n).

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