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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

NORBROOK INC: Oxytetracycline Injection Solutions Recalled for Cloudy Appearance

Agency Publication Date: December 10, 2018
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Summary

Norbrook Inc. has recalled approximately 62,732 vials of 300 Pro LA (oxytetracycline injection) and Noromycin 300LA (oxytetracycline injection), which are antibiotic medications used for livestock. The recall was initiated because the normally clear liquid in the vials was observed to have a cloudy appearance, suggesting a potential quality or stability defect. While no specific animal health incidents have been reported, consumers should check their inventory for the specific lot numbers and expiration dates listed below. If you have these products, you should stop using them immediately and contact your veterinarian or the manufacturer for guidance on returns.

Risk

The cloudy appearance in these injectable medications indicates a potential breakdown in the product's formulation or contamination. Injecting a compromised or unstable solution into an animal can lead to reduced effectiveness of the antibiotic treatment or localized reactions at the injection site.

What You Should Do

  1. Check your inventory for 300 Pro LA (oxytetracycline injection) 300 mg/mL in 100 mL, 250 mL, or 500 mL vials with lot numbers 8081-603B (Exp Feb 2021); 8133-601C, 8133-601D, 8133-602B (Exp March 2021); or 8232-601B (Exp June 2021).
  2. Check your inventory for Noromycin 300LA (oxytetracycline injection) 300 mg/mL in 100 mL, 250 mL, or 500 mL vials with lot numbers 8133-601A, 8133-601B, 8133-601E, 8133-602A (Exp March 2021); 7311-601A (Exp July 2020); 7312-601A (Exp August 2020); 8081-603A, 8082-600A (Exp Feb 2021); 8223-601A, 8224-600A, 8224-600B (Exp May 2021); or 8232-602A, 8251-600A (Exp June 2021).
  3. Stop using the affected product immediately if the lot number matches those listed above or if the solution appears cloudy.
  4. Contact your veterinarian or pharmacist to discuss alternative treatments and to report any adverse events observed in treated animals.
  5. Return any unused vials to the place of purchase for a refund or contact Norbrook Inc. at their Overland Park, Kansas headquarters for return instructions.
  6. For additional questions, contact the FDA Center for Veterinary Medicine at 240-402-7002.

Your Remedy Options

💰Full Refund

Veterinary medication refund/return

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

Affected Products

Product: 300 Pro LA (oxytetracycline injection), 300 mg/mL (100, 250 or 500 mL)
Model:
NADA 141-143
V-0047-2019
Lot Numbers:
8081-603B (exp February 2021)
8133-601C (exp March 2021)
8133-601D (exp March 2021)
8133-602B (exp March 2021)
8232-601B (exp June 2021)
Date Ranges: February 2021, March 2021, June 2021
Product: Noromycin 300LA (oxytetracycline injection), 300 mg/mL (100, 250 or 500 mL)
Model:
NADA 141-143
V-0048-2019
Lot Numbers:
8133-601A (exp March 2021)
8133-601B (exp March 2021)
8133-601E (exp March 2021)
8133-602A (exp March 2021)
7311-601A (exp July 2020)
7312-601A (exp August 2020)
8081-603A (exp February 2021)
8082-600A (exp February 2021)
8223-601A (exp May 2021)
8224-600A (exp May 2021)
8224-600B (exp May 2021)
8232-602A (exp June 2021)
8251-600A (exp June 2021)
Date Ranges: July 2020, August 2020, February 2021, March 2021, May 2021, June 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81298
Status: Resolved
Manufacturer: NORBROOK INC
Sold By: Authorized distributors; Veterinary clinics
Manufactured In: United States
Units Affected: 2 products (8,305 vials; 54,427 vials)
Distributed To: Iowa, Idaho, Missouri, Kentucky, Arkansas, Virginia, North Carolina, Nebraska, Puerto Rico
Agency Last Updated: December 17, 2018

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