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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: Gentamicin Sulfate Solution Recalled Due to Water Leak in Filling Room

Agency Publication Date: June 29, 2010
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Summary

Sparhawk Laboratories Inc is recalling 14,677 vials of Gentamicin Sulfate Solution (100 mg/ml), a prescription veterinary antibiotic used in animals. The recall includes multiple brands such as VEDCO GentaVed 100, AgriLabs LEGACY, Phoenix Pharmaceutical GentaMax 100, RXV, VetTek, and Butler GENTAFUSE. This recall was initiated because a water leak occurred in the fill room outside the filling line during production, which could compromise the sterility or quality of the medication.

Risk

A water leak in a sterile processing environment introduces the risk of environmental contaminants entering the production area. If the sterility of this injectable medication is compromised, it could lead to serious infections or adverse health reactions in animals receiving the treatment.

What You Should Do

  1. Identify if you have any of the affected 100-ml vials by checking the brand name and NDC numbers: VEDCO GentaVed 100 (NDC 50989-040-12), AgriLabs LEGACY (NDC 57561-336-04), Phoenix Pharmaceutical GentaMax 100 (NDC 57319-520-05), VetTek Gentamicin Sulfate (NDC 60270-338-10), or Butler GENTAFUSE (NDC 11695-4146-1).
  2. Check your supply for RXV Gentamicin Sulfate Solution (manufactured for RXVeterinary Products) or GentaMax 100 manufactured for Clipper Distributing Co., LLC.
  3. Immediately stop using the affected medication and quarantine any remaining stock to ensure it is not administered to animals.
  4. Contact your veterinarian, healthcare provider, or pharmacist for guidance regarding animals that may have already been treated with this product.
  5. Return any unused vials to the pharmacy or wholesale distributor where they were purchased for a refund.
  6. Contact Sparhawk Laboratories Inc at their Lenexa, Kansas facility for further instructions regarding product return or replacement.
  7. For additional questions, contact the FDA Center for Veterinary Medicine at 240-402-7002.

Your Remedy Options

💰Full Refund

Contact healthcare provider and return product.

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

Affected Products

Product: VEDCO GentaVed 100 Gentamicin Sulfate Solution (100-ml)
Model:
NDC 50989-040-12
ANDA 200-395
Product: AgriLabs LEGACY Gentamicin Sulfate Solution (100-ml)
Model:
NDC 57561-336-04
ANDA 200-395
Product: Phoenix Pharmaceutical, Inc. GentaMax 100 (100-ml)
Model:
NDC 57319-520-05
ANDA 200-395
Product: RXV Gentamicin Sulfate Solution (100-ml)
Model:
ANDA 200-395
Product: VetTek Gentamicin Sulfate Solution (100-ml)
Model:
NDC 60270-338-10
ANDA 200-395
Product: Butler GENTAFUSE Gentamicin Sulfate Solution (100-ml)
Model:
NDC 11695-4146-1
ANDA 200-395

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 55932
Status: Resolved
Manufacturer: Sparhawk Laboratories Inc
Sold By: VEDCO, INC.; Agri Laboratories, Ltd.; Clipper Distributing Co., LLC; RXVeterinary Products; VetTek; Butler Animal Health Supply; Wholesale distributors
Manufactured In: United States
Units Affected: 14,677/100-ml. vials
Distributed To: Missouri, Tennessee, Ohio

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