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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
Medications & Supplements/Veterinary Medicines

Norbrook Laboratories, Ltd.: Hexasol Injection Recalled for Suspended Crystals in Solution

Agency Publication Date: May 8, 2019
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Summary

Norbrook Laboratories is recalling 39,025 vials of Hexasol Injection (oxytetracycline and flunixin meglumine), a veterinary medication used for cattle. The recall was issued because crystals were found floating in the injectable solution, which should be clear of such particles. Consumers should check their supply for 250 mL and 500 mL vials from specific batches expiring in April 2019 and February 2020.

Risk

Injecting a solution containing suspended crystals can cause serious health issues for the animal, including irritation or blockages in the bloodstream at the injection site. No specific animal injuries have been reported in this notice, but the presence of solids in an injectable product is a significant manufacturing defect.

What You Should Do

  1. Identify if you have Hexasol Injection (oxytetracycline & flunixin meglumine) in 250 mL vials (NDC: 55529-016-04) or 500 mL vials (NDC: 55529-016-05).
  2. Check the packaging for the following affected Batch Numbers: 7152-90A, 7152-91A, 7153 90A, 7173 98A, 7173 98B, 7175 90A (all expiring April 2019) or Batch Number 8073-90A (expiring February 2020).
  3. Immediately stop using any vials from the affected batches and isolate them to ensure they are not administered to livestock.
  4. Contact your veterinarian or pharmacist for guidance regarding the use of this medication and to arrange for the return of any unused product.
  5. Contact Norbrook Laboratories Limited at their United Kingdom headquarters or through their U.S. distribution channels to report affected product and inquire about a refund.
  6. For additional questions, contact the FDA Center for Veterinary Medicine at 240-402-7002 or via email at AskCVM@fda.hhs.gov.

Your Remedy Options

๐Ÿ’ฐFull Refund

Pharmacist or Healthcare Provider guidance and refund

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

Affected Products

Product: Hexasol Injection (oxytetracycline & flunixin meglumine) (250 mL)
Model:
NDC: 55529-016-04
Lot Numbers:
7152-90A (Exp April 2019)
7152-91A (Exp April 2019)
7153 90A (Exp April 2019)
7173 98A (Exp April 2019)
7173 98B (Exp April 2019)
7175 90A (Exp April 2019)
8073-90A (Exp February 2020)
Date Ranges: April 2019, February 2020
Product: Hexasol Injection (oxytetracycline & flunixin meglumine) (500 mL)
Model:
NDC: 55529-016-05
Lot Numbers:
7152-90A (Exp April 2019)
7152-91A (Exp April 2019)
7153 90A (Exp April 2019)
7173 98A (Exp April 2019)
7173 98B (Exp April 2019)
7175 90A (Exp April 2019)
8073-90A (Exp February 2020)
Date Ranges: April 2019, February 2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80749
Status: Resolved
Manufacturer: Norbrook Laboratories, Ltd.
Manufactured In: United Kingdom
Units Affected: 39,025 vials
Distributed To: Missouri, Texas, Kansas, Puerto Rico
Agency Last Updated: May 10, 2019

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