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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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Critical RiskFDA Vet
Pets & Animals/Pet Medications

Bayer Health Care Llc: Baytril Antimicrobial Solution Recalled Due to FDA Withdrawal of Approval

Agency Publication Date: November 29, 2005
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Summary

Bayer HealthCare LLC is recalling approximately 51,515 gallons of Baytril (enrofloxacin) 3.23% Concentrate Antimicrobial Solution because the FDA has withdrawn the product's approval. This prescription medication, which was intended for use only in the drinking water of chickens and turkeys, was packaged in 1-gallon bottles and distributed in 4-bottle cases. Consumers and distributors should immediately stop using and distributing this specific antimicrobial solution as it is no longer authorized for use.

Risk

The FDA has withdrawn the approval of this product, meaning it has determined the drug is no longer proven to be safe and effective for its intended use in poultry drinking water.

What You Should Do

  1. Check your inventory for Baytril (enrofloxacin) 3.23% Concentrate Antimicrobial Solution packaged in 1-gallon bottles (4 bottles per case).
  2. Verify the label identifies the manufacturer as Bayer HealthCare LLC, Animal Health Division, Shawnee Mission, KS, and lists NADA 140-828.
  3. Immediately stop using this product for any poultry and cease all further distribution.
  4. Contact your veterinarian or healthcare provider to discuss alternative antimicrobial treatments that are currently FDA-approved.
  5. Return any unused product to the place of purchase for a refund and contact Bayer Health Care Llc at 12707 Shawnee Mission Pkwy, Shawnee, KS 66216 for further disposal instructions.
  6. For additional questions or to report adverse events, contact the FDA Center for Veterinary Medicine (CVM) at 240-402-7002.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product 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: Baytril (enrofloxacin) 3.23% Concentrate Antimicrobial Solution (1-gal. bottle)
Model:
NADA 140-828
Recall #: V-011-6

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 33363
Status: Resolved
Manufacturer: Bayer Health Care Llc
Sold By: agents; distributors
Manufactured In: United States
Units Affected: 51,515 gallons
Distributed To: North Carolina, Texas, Minnesota, Georgia, Iowa

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