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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
Medications & Supplements/Veterinary Medicines

Fougera Pharmaceuticals Inc.: Animax Ointment Recalled Due to Higher-Than-Expected Drug Potency

Agency Publication Date: July 11, 2011
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Summary

Fougera Pharmaceuticals Inc. is recalling 30 mL tubes of Animax Ointment (nystatin-neomycin sulfate-thiostrepton-triamcinolone acetonide) from Lot 572C. This veterinary medication is commonly used to treat skin and ear conditions in animals. The recall was initiated after stability testing revealed that the medication was 'super-potent,' meaning it contained levels of neomycin sulfate that exceeded the required specification. Owners of pets using this ointment should check their lot numbers and consult their veterinarian regarding continued use.

Risk

The ointment contains higher concentrations of neomycin sulfate than intended, which could lead to adverse reactions or localized side effects in pets treated with this specific lot.

What You Should Do

  1. Check your pet's medication tube or outer packaging for Lot 572C.
  2. Verify the product details on the label, specifically looking for 'ANIMAX OINTMENT' in the 30 mL size with NDC 17033-122-30 and ANADA #140-847.
  3. Contact your veterinarian or pharmacist for guidance on whether to continue using the ointment and to discuss potential alternative treatments for your pet.
  4. Return any unused product from the affected lot to the pharmacy or place of purchase for a refund.
  5. Contact the manufacturer, Fougera Pharmaceuticals Inc., for further instructions regarding this recall.
  6. For additional questions, contact the FDA at 1-888-463-6332.

Your Remedy Options

💰Full Refund

Veterinary drug return and refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the place of purchase for a refund, and contact the manufacturer for further instructions.

Affected Products

Product: ANIMAX OINTMENT, nystatin-neomycin sulfate-thiostrepton-triamcinolone acetonide ointment (30 mL)
Model:
ANADA #140-847
NDC 17033-122-30
V-369-2011
Lot Numbers:
572C

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 59180
Status: Resolved
Manufacturer: Fougera Pharmaceuticals Inc.
Sold By: Dechra Veterinary products
Manufactured In: United States
Distributed To: Kansas

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