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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

Novartis Animal Health US Inc: Atopica (cyclosporine) Recalled for Potential Packaging and Dosage Error

Agency Publication Date: July 30, 2010
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Summary

Novartis Animal Health US Inc is recalling approximately 3,978 units of Atopica (cyclosporine capsules) because outer cartons labeled as 100 mg may actually contain 50 mg capsules. This packaging error means a pet could receive only half of their intended medication dose, which can lead to ineffective treatment of their condition. The affected products were distributed in seven states and are packaged in blister packs containing 15 capsules.

Risk

The incorrect dosage means the pet is not receiving the level of medication prescribed by their veterinarian, potentially causing a recurrence of symptoms or a failure to manage the animal's underlying medical condition.

What You Should Do

  1. Check the outer carton and the internal blister packs of your Atopica (cyclosporine) 100 mg medication to ensure the dosage printed on the individual blister pack matches the 100 mg box.
  2. Identify if your product is labeled with Recall Number V-191-2010.
  3. If you find 50 mg capsules inside a 100 mg labeled box, do not administer the lower dose to your pet if they were prescribed 100 mg.
  4. Contact your veterinarian or pharmacist immediately to report the error and ensure your pet receives the correct prescribed dosage.
  5. Return any mislabeled or unused medication to the pharmacy or place of purchase for a full refund.
  6. Contact Novartis Animal Health US Inc at their Greensboro, NC headquarters for further instructions regarding this recall.
  7. For additional consumer safety questions, contact the FDA at 1-888-INFO-FDA (1-888-463-6332).

Your Remedy Options

💰Full Refund

Return to the pharmacy for a refund.

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

Affected Products

Product: ATOPICA (Cyclosporine Capsules USP), Modified, 50 mg or 100 mg (15 capsules)
Model:
V-191-2010

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 56020
Status: Resolved
Manufacturer: Novartis Animal Health US Inc
Sold By: Veterinary clinics; Pharmacies
Manufactured In: Germany, United States
Units Affected: 3978 units
Distributed To: Idaho, Massachusetts, Maryland, Nebraska, Ohio, Oregon, Texas

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