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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

Orbax (orbifloxacin tablets) Recalled for Mislabeling

Agency Publication Date: May 13, 2022
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Summary

Intervet, Inc. (Merck Animal Health) has recalled 2,404 bottles of Orbax (orbifloxacin tablets) because they were mislabeled. This recall affects 22.7 mg tablets (250-count bottles) and 68 mg tablets (100-count bottles) distributed nationwide to veterinary clinics and pharmacies. No incidents or injuries have been reported, but correct labeling is critical to ensure pets receive the proper dosage and medication.

Risk

Mislabeling on medication can lead to administering the wrong dosage or the wrong drug to an animal, which may result in ineffective treatment or adverse health reactions.

What You Should Do

  1. Check your Orbax (orbifloxacin tablets) bottles for the following identifying information: 22.7 mg strength with NDC 0061-1141-01 and lot 28010015, or 68 mg strength with NDC 0061-1174-01 and lot 28020014.
  2. If you have animal health concerns, contact your veterinarian. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer or supplier for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: If you have animal health concerns, contact your veterinarian. Return any unused product to the place of purchase for a refund, or contact the manufacturer or supplier for further instructions
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away.

Affected Products

Product: Orbax (orbifloxacin tablets) 22.7 mg (250 Tablets)by Orbax
Variants: 22.7 mg, Tablet
Lot Numbers:
28010015
NDC:
0061-1141-01

Recall #: V-0142-2022; Quantity: 1,562 bottles

Product: Orbax (orbifloxacin tablets) 68 mg (100 Tablets)by Orbax
Variants: 68 mg, Tablet
Lot Numbers:
28020014
NDC:
0061-1174-01

Recall #: V-0143-2022; Quantity: 842 bottles

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90024
Status: Resolved
Manufacturer: Intervet, Inc
Sold By: veterinary clinics; pharmacies
Manufactured In: United States
Units Affected: 2 products (1,562 bottles; 842 bottles)
Distributed To: Nationwide
Agency Last Updated: May 18, 2022

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