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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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Medium RiskFDA Vet
Pets & Animals/Pet Medications

Virbac Inc: Soloxine (levothyroxine sodium) Tablets Recalled for Quality Specification Failure

Agency Publication Date: August 24, 2011
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Summary

Approximately 24,468 bottles of Virbac Animal Health Soloxine (levothyroxine sodium) prescription tablets are being recalled because specific product lots failed to meet established quality specifications. The recall affects 0.2 mg, 0.3 mg, and 0.6 mg strengths in both 250-count and 1,000-count bottle sizes. Because the medication did not meet required standards, it may not provide the precise dosage intended for the animal's thyroid treatment. Owners of pets using this medication should contact their veterinarian or pharmacist for guidance and to obtain a replacement from a non-affected lot.

Risk

The product failed to meet established specifications, which could result in the medication being over-potent or under-potent. This may lead to ineffective treatment of hypothyroidism or potential toxicity in pets if the dose is higher than specified.

What You Should Do

  1. Check your pet's medication bottle for the brand name Soloxine (levothyroxine sodium) and verify the dosage strength (0.2 mg, 0.3 mg, or 0.6 mg).
  2. Identify if your bottle is a 250-count or 1,000-count size and look for NDC codes: 051311-832-10 or 51311-832-25 (0.2 mg); 051311-833-10 or 051311-833-25 (0.3 mg); or 051311-836-10 or 051311-836-25 (0.6 mg).
  3. Contact your veterinarian or pharmacist immediately to determine if your specific bottle is part of the affected lots and to arrange for a replacement medication.
  4. Return any unused tablets to the pharmacy or veterinary clinic where they were purchased for a full refund.
  5. Contact the manufacturer, Virbac Inc, at their Bridgeton, Missouri headquarters if you have further questions regarding the product quality issue.
  6. For additional information, you may contact the FDA Center for Veterinary Medicine at 1-240-402-7002.

Your Remedy Options

💰Full Refund

Refund and replacement of medication.

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

Affected Products

Product: Virbac Animal Health Soloxine (levothyroxine sodium) Tablets, 0.2 mg (1,000-ct. btl)
Model:
NDC 051311-832-10
V-394-2011
Product: Virbac Animal Health Soloxine (levothyroxine sodium) Tablets, 0.2 mg (250-ct. btl)
Model:
NDC 51311-832-25
V-394-2011
Product: Virbac Animal Health Soloxine (levothyroxine sodium) Tablets, 0.3 mg (1,000-ct. btl)
Model:
NDC 051311-833-10
V-395-2011
Product: Virbac Animal Health Soloxine (levothyroxine sodium) Tablets, 0.3 mg (250-ct. btl)
Model:
NDC 051311-833-25
V-395-2011
Product: Virbac Animal Health Soloxine (levothyroxine sodium) Tablets, 0.6 mg (1,000-ct. btl)
Model:
NDC 051311-836-10
V-396-2011
Product: Virbac Animal Health Soloxine (levothyroxine sodium) Tablets, 0.6 mg (250-ct. btl)
Model:
NDC 051311-836-25
V-396-2011

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 57263
Status: Resolved
Manufacturer: Virbac Inc
Sold By: vet drug distributors
Manufactured In: United States
Units Affected: 3 products (3,660 bottles (2,388/250-ct. and 1,272/1,000-ct. btls); 7,020 bottles (4,668/250-ct. and 2,352/1,000-ct. btls); 13,788 bottles (8,580/250-ct and 5,208/1,000-ct. btls))
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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