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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 Drug
Medications & Supplements/Prescription Drugs

Hylenex (hyaluronidase) Injection Recalled for Temperature Excursion

Agency Publication Date: December 10, 2024
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Summary

McKesson Medical-Surgical Inc. has recalled five cartons of Hylenex recombinant (hyaluronidase) injection because the product was exposed to temperatures outside of required storage limits. This recall affects the 150 USP units/mL strength, which is packaged in cartons containing four 1 mL single-dose vials. Consumers and healthcare providers should check for specific serial numbers listed in the recall to determine if their medication is affected. If you have any health concerns, please consult a healthcare professional.

Risk

The medication was subjected to a temperature excursion, which means it was stored or shipped at temperatures that could potentially compromise the product's effectiveness or stability.

What You Should Do

  1. This recall affects Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, sold in cartons of four 1 mL single-dose vials (NDC 18657-117-04).
  2. Check the packaging for the following serial numbers to identify affected units: 100000831961, 100000820688, 100000820689, or 100000820515.
  3. Stop using the recalled product immediately.
  4. Contact McKesson Medical-Surgical Inc. or your distributor to arrange for the return of any affected medication.
  5. If you have health concerns, contact your healthcare provider or pharmacist.
  6. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action

Professional/Clinical return coordination

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Hylenex recombinant (hyaluronidase) injection (150 USP units/mL)
Variants: 150 USP units/mL, 4x1 mL Single Dose Vials
Serial Numbers:
100000831961
100000820688
100000820689
100000820515
NDC:
18657-117-04

Manufactured for Halozyme, Inc. and distributed by Antares Pharma, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95830
Status: Resolved
Manufacturer: Mckesson Medical-Surgical Inc. Corporate Office
Sold By: McKesson Medical-Surgical Inc.
Manufactured In: United States
Units Affected: 5 cartons/20 units each carton
Distributed To: Virginia
Agency Last Updated: December 11, 2024

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

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.