Recall archive / FDA drug enforcement
Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for ... — FDA record D-0116-2025
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 11, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- Reason
- cGMP Deviations: Temperature excursion
- Classification
- Class II
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Quantity
- 5 cartons/20 units each carton
- Agency-reported status
- Terminated
- Source record identifier
- D-0116-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Serial # 100000831961 100000820688 100000820689 100000820515 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Virgina
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Dec 18, 2024
- Recall initiation date
- Sep 11, 2024
- Center classification date
- Dec 10, 2024
- Termination date
- Aug 20, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.