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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

TEVA Animal Health Inc: Oxytetracycline Injection Recalled for Manufacturing and Filtration Defects

Agency Publication Date: October 26, 2009
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Summary

TEVA Animal Health Inc. is recalling 6,951 units of Oxytetracycline Hydrochloride Injection (100 mg/ml) sold in 500-ml bottles under several brand names including Maxim 100, Butler Oxybiotic 100, Terra-Vet 100, Duramycin-100, and Agripharm Oxy-Mycin 100. The recall was initiated because the total filtration time during production exceeded safety specifications and the products were not manufactured in accordance with Good Manufacturing Practices (GMP). These medications are used for animal health and were distributed through various veterinary suppliers and distributors. Consumers should contact their veterinarian or pharmacist regarding any unused product.

Risk

Failure to follow proper filtration times and manufacturing standards can compromise the sterility and quality of the injectable medication, potentially leading to ineffective treatment or adverse reactions in animals.

What You Should Do

  1. Check your supply for 500-ml bottles of Oxytetracycline Hydrochloride Injection (100 mg/ml) sold under the following labels: Maxim 100 (NDC 59130-673-03), Butler Oxybiotic 100 (NDC 11695-3533-3), Terra-Vet 100 Injectable, Duramycin-100 (NDC 30798-577-17), or Agripharm Oxy-Mycin 100.
  2. Verify if your product matches the ANADA number 200-068 located on the packaging.
  3. Contact your veterinarian or pharmacist immediately to determine if the specific lot in your possession is part of this recall and to discuss alternative treatment options.
  4. Return any unused or affected product to the pharmacy or distributor where it was purchased for a refund.
  5. Contact TEVA Animal Health Inc at their Saint Joseph, Missouri facility for further instructions regarding the return process.
  6. For additional questions, contact the FDA Center for Veterinary Medicine at 1-240-402-7002.

Your Remedy Options

💰Full Refund

Return product to place of purchase

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

Affected Products

Product: AmTech Group, Inc. Maxim 100 Oxytetracycline Hydrochloride Injection (500-ml)
Model:
NDC 59130-673-03
ANADA 200-068
Product: Butler Oxybiotic 100 Oxytetracycline Hydrochloride Injection (500-ml)
Model:
NDC 11695-3533-3
ANADA 200-068
Product: Terra-Vet 100 Injectable Oxytetracycline Hydrochloride Injection (500-ml)
Model:
ANADA 200-068
Product: Durvet Duramycin-100 Oxytetracycline Hydrochloride Injection (500-ml)
Model:
NDC 30798-577-17
ANADA 200-068
Product: Agripharm Oxy-Mycin 100 Oxytetracycline Hydrochloride Injection (500-ml)
Model:
ANADA 200-068

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 53037
Status: Resolved
Manufacturer: TEVA Animal Health Inc
Sold By: AmTech Group, Inc.; Butler Animal Health Supply; Aspen Veterinary Resources Ltd.; Durvet, Inc.; Agripharm Products
Manufactured In: United States
Units Affected: 6,951/500-ml. btls.
Distributed To: Ohio, Georgia, Florida, Pennsylvania, Illinois, Kentucky, New York, Tennessee, Texas, Oregon, Utah, Missouri, 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 · Raw API Response