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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

Novartis Animal Health US Inc: Deramaxx (deracoxib) 25 mg and 100 mg Dog Tablets for Assay Specifications

Agency Publication Date: July 19, 2005
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Summary

Novartis Animal Health US Inc. has recalled 4,530 bottles of Deramaxx (deracoxib) chewable tablets used for pain and inflammation in dogs because the medication does not meet finished product assay specifications. The recall affects Deramaxx 25 mg tablets in 30-count and 90-count bottles, as well as Deramaxx 100 mg tablets in 90-count bottles. This means the actual amount of active medication in the tablets may differ from what is stated on the label, which could impact the effectiveness or safety of the treatment. These products were distributed in California, Georgia, and Hawaii.

Risk

If the tablets do not meet assay specifications, a dog may receive more or less of the medication than intended. This could lead to an ineffective treatment of pain or, in the case of over-potency, an increased risk of side effects associated with NSAIDs, such as gastrointestinal or kidney issues.

What You Should Do

  1. Check your dog's medication bottles for Deramaxx (deracoxib) 25 mg (Recall #: V-091-5) or 100 mg (Recall #: V-092-5) tablets manufactured for Novartis Animal Health US, Inc.
  2. Identify if your bottle is a 30-count or 90-count plastic screw-top bottle of the 25 mg strength, or a 90-count bottle of the 100 mg strength.
  3. Contact your veterinarian or healthcare provider immediately for guidance on whether to continue use or if your dog requires a replacement prescription.
  4. Return any unused product to the pharmacy or veterinarian's office where it was purchased for a refund.
  5. Contact Novartis Animal Health US Inc. at their Greensboro, NC headquarters for further instructions regarding this recall.
  6. For additional questions, contact the FDA's Center for Veterinary Medicine at 1-240-402-7002.

Your Remedy Options

💰Full Refund

Drug Recall Refund/Guidance

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Dermaxx¿ (deracoxib) 25 mg tablets (30 and 90 tablets per bottle)
Model:
V-091-5
Product: Deramaxx (deracoxib) 100 mg tablets (90 tablets per bottle)
Model:
V-092-5

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 32470
Status: Active
Manufacturer: Novartis Animal Health US Inc
Sold By: veterinary clinics; pharmacies
Manufactured In: United States
Units Affected: 2 products (unknown; 4530 bottles)
Distributed To: California, Georgia, Hawaii

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 · Raw API Response