Drug FDA Class II Terminated cGMP deviation
Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halozyme, Inc., 12390 El Camino Real San Diego California 92130, Distributed by Antares Pharma, Inc., Ewing, NJ NDC 18657-117-04
Mckesson Medical-Surgical Inc. Corporate Office Published Dec 18, 2024
Risk level
Class IIMay cause a temporary or reversible health problem; slight chance of serious harm.
Severity score 45/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Mckesson Medical-Surgical Inc. Corporate Office or your place of purchase with questions, and see the source record below for full details.
Reason for recall
cGMP Deviations: Temperature excursion
Hazards
Temperature Excursion · primary
Affected products (1)
Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halozyme, Inc., 12390 El Camino Real San Diego California 92130, Distributed by Antares Pharma, Inc., Ewing, NJ NDC 18657-117-04
HYLENEX RECOMBINANT · 5 cartons/20 units each carton
NDC: 18657-117, 18657-117-01, 18657-117-02, 18657-117-04, 1000008319, 1000008206, 1000008205
Code info: Serial # 100000831961 100000820688 100000820689 100000820515
Affected areas
Virgina
Timeline
- InitiatedSep 11, 2024
- PublishedDec 18, 2024
- TerminatedAug 20, 2025
- Recall number
- D-0116-2025
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.