The Recall Desk
HighFDA (Drugs)·D-0116-2025·Announced 2024-12-18

Injectable drug recalled for temperature excursion during storage

Mckesson Medical-Surgical Inc. is recalling HYLENEX RECOMBINANT (hyaluronidase) injection due to cGMP deviations involving a temperature excursion during storage, which may have compromised drug potency.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall involves a cGMP deviation (temperature excursion) affecting an injectable pharmaceutical product. While no illnesses or injuries have been reported, the temperature excursion poses a risk of compromised drug potency and stability, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

HYLENEX RECOMBINANT (hyaluronidase) injection, 150 USP units/mL, supplied in 4×1 mL single-dose vials, is being recalled. The affected product was distributed in Virginia.

The recall was initiated due to cGMP deviations identified during manufacturing. Specifically, a temperature excursion occurred during product storage. Temperature control is critical for maintaining the stability, potency, and safety of injectable pharmaceutical products. The temperature excursion may have compromised the drug's efficacy.

The recalling firm is Mckesson Medical-Surgical Inc. The product is manufactured and marketed by Halozyme, Inc., located in San Diego, California, and distributed by Antares Pharma, Inc., located in Ewing, New Jersey.

Patients and healthcare providers who have received affected units should contact their healthcare provider. Healthcare providers should verify the lot numbers of HYLENEX RECOMBINANT they have in stock and take appropriate action regarding potentially affected patients.

The recalled product

Product
HYLENEX RECOMBINANT (HYALURONIDASE)
Brand
HYLENEX RECOMBINANT
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug — Injectable
Hazard
  • temperature-excursion
  • potency-loss

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial # 100000831961 100000820688 100000820689 100000820515

Distribution

Distribution scope not specified by the agency.

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