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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

Sparhawk Laboratories Inc: Butler Butaject (Phenylbutazone) Recalled for Conflicting Labeling Instructions

Agency Publication Date: September 16, 2008
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Summary

Sparhawk Laboratories Inc is recalling approximately 8,388 bottles of Butler Butaject (phenylbutazone injection), a 200 mg/mL medication used for horses. One part of the product label incorrectly instructs that the drug should be administered into the uterus (intrauterine), while another section correctly states it is for injection into a vein (intravenous). This conflicting information could lead to the medication being administered via the wrong route, which may cause serious health complications for the animal or lead to ineffective treatment.

Risk

If the medication is administered into the uterus instead of the vein as intended, it could cause localized injury, infection, or fail to provide the necessary systemic treatment for the horse's condition. There are currently no reports of animal injuries related to this labeling error.

What You Should Do

  1. Check your supply for Butler Butaject (Phenylbutazone Injection), 200 mg/mL, in 100-mL bottles with NDC #11695-4144-1 and ANDA #200-371.
  2. Inspect the label for conflicting administration instructions that mention both 'intravenous' and 'intrauterine' use.
  3. Contact your veterinarian or healthcare provider immediately for guidance on using this medication or if your animal has already received it.
  4. Return any unused bottles of the affected medication to the place of purchase for a full refund and contact Sparhawk Laboratories Inc for further instructions.
  5. For additional questions, contact the FDA Center for Veterinary Medicine at 240-402-7002.

Your Remedy Options

๐Ÿ’ฐFull Refund

Veterinary drug return

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

Affected Products

Product: Butler Butaject (Phenylbutazone Injection), 200 mg/mL (100-mL)
Model:
ANDA #200-371
NDC #11695-4144-1
V-247-2008

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 49133
Status: Resolved
Manufacturer: Sparhawk Laboratories Inc
Sold By: Butler Animal Health Supply; distribution centers
Manufactured In: United States
Units Affected: 8,388/100-ml. bottles
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 ยท Raw API Response