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Low RiskFDA Vet
Pets & Animals/Pet Medications

Virbac AH, Inc: Virbac Soloxine Tablets Recalled for Missing Dates and Foreign Tablet Presence

Agency Publication Date: January 23, 2015
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Summary

Virbac AH, Inc. has recalled approximately 14,000 bottles of Soloxine (levothyroxine sodium) Tablets, a medication used for thyroid conditions in animals. The recall involves 0.1mg, 0.2mg, and 0.8mg strengths in both 250 and 1000 count bottles after it was discovered that some products were missing expiration dates and lot numbers, and one instance of a foreign tablet was found in a bottle. These products were distributed to various states including CA, FL, TX, and others through veterinary distribution channels.

Risk

The absence of expiration dates and lot numbers makes it impossible for users to know if the medication is still effective or safe to use. Additionally, the presence of a foreign tablet in the medication bottle poses a risk of incorrect dosing or exposure to an unintended substance, which could cause adverse health effects for the animal.

What You Should Do

  1. Check your pet's medication bottles for Virbac Soloxine (levothyroxine sodium) Tablets in the following strengths: 0.1mg (NDC 051311-831-25), 0.2mg (NDC 051311-832-25), or 0.8mg (NDC 051311-838-25).
  2. Verify the lot numbers on your bottles; affected lot numbers include 130846 (0.1mg), 141103 (0.2mg), and 130921 (0.8mg).
  3. Inspect the labels specifically to see if the required expiration date or lot number is missing from the packaging.
  4. If you identify an affected bottle or find a tablet that looks different from the others, contact your veterinarian or pharmacist immediately to discuss your pet's care and obtain a replacement.
  5. Return any unused or incorrectly labeled product to the pharmacy or veterinarian where you purchased it for a refund.
  6. Contact Virbac AH, Inc. at their Fort Worth, Texas headquarters for further information regarding this voluntary recall.
  7. For additional questions, you may contact the FDA Center for Veterinary Medicine at 240-402-7002.

Your Remedy Options

๐Ÿ’ฐFull Refund

Refund for unused 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 Soloxine (levothyroxine sodium) Tablets, 0.1mg (250 and 1000 count bottles)
Model:
NDC 051311-831-25
V-217-2015
Lot Numbers:
130846
Product: Virbac Soloxine (levothyroxine sodium) Tablets, 0.2mg (250 count bottles)
Model:
NDC 051311-832-25
V-218-2015
Lot Numbers:
141103
Product: Virbac Soloxine (levothyroxine sodium) Tablets, 0.8mg (250 and 1000 count bottles)
Model:
NDC 051311-838-25
V-219-2015
Lot Numbers:
130921

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 70083
Status: Resolved
Manufacturer: Virbac AH, Inc
Sold By: Veterinary clinics; Animal pharmacies
Manufactured In: United States
Units Affected: 3 products (0.1mg - 1,392/1000 and 1,344/250 count/bottles; 0.2mg - 3,156/250 count/bottles; 0.8mg - 1,200/1000 and 3,648/250 count/bottles)
Distributed To: California, Florida, Hawaii, Iowa, Indiana, Michigan, Minnesota, Missouri, Nebraska, Oregon, Pennsylvania, Tennessee, Texas, Wisconsin, Guam, Puerto Rico

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