FDA Drug recall D-0116-2025
Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halozy…
- FDA Drug
- Class II
- terminated
- Published 2024-12-18
On 2024-12-18 the FDA classified a Class II recall of Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halozy… by Mckesson Medical Surgical Corporate Office, citing cGMP Deviations: Temperature excursion.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0116-2025 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-09-11 |
| Published | 2024-12-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mckesson Medical Surgical Corporate Office |
| Distribution | n/a |
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
Identifiers
| ndc | 18657-117-01 |
|---|---|
| ndc | 18657-117-02 |
| ndc | 18657-117-04 |
| ndc | 1000008319 |
| ndc | 1000008206 |
| ndc | 1000008205 |
| code_info | Serial # 100000831961 100000820688 100000820689 100000820515 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0116-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.