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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Vet
Pets & Animals/Pet Medications

Duoxo Calm Serum Recalled for CGMP Violations

Agency Publication Date: November 27, 2024
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Summary

Ceva Animal Health, LLC is recalling 2,916 bottles of Duoxo Calm Serum, a topical treatment for dogs and cats. The recall was initiated because of violations in Current Good Manufacturing Practice (CGMP) standards, which are the regulations enforced by the FDA to ensure product quality and safety. Consumers who have this serum should stop using it on their pets and check the lot number and expiration date on the 2 fl oz (60mL) bottle.

Risk

The failure to follow required manufacturing quality standards means the safety, identity, and purity of the serum cannot be guaranteed, potentially posing a risk of irritation or ineffective treatment for pets.

What You Should Do

  1. Check your bottle of Duoxo Calm Serum to see if it matches Lot 240246 with an expiration date of 5/9/2026.
  2. If you have animal health concerns or notice any adverse reactions in your pet after using this product, contact your veterinarian immediately.
  3. Return any unused product to the place of purchase for a refund, throw it away, or contact Ceva Animal Health, LLC for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 if you have additional questions or wish to report a problem.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: If you have animal health concerns, contact your veterinarian. Return any unused product to the place of purchase for a refund, or contact the manufacturer or supplier for further instructions
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away.

Affected Products

Product: Duoxo Calm Serum (2 fl oz / 60mL)by Duoxo
Variants: Phytosphingosine salicyloyl 0.2%, For Use on Dogs and Cats
Lot Numbers:
240246 (Exp 5/9/2026)

Recall #: V-0044-2025; Manufactured for Ceva Animal Health, LLC

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95771
Status: Resolved
Manufacturer: Ceva Animal Health, LLC
Sold By: Veterinary clinics; Pet specialty retailers
Manufactured In: United States
Units Affected: 2916 bottles
Distributed To: Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin
Agency Last Updated: December 13, 2024

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response