Hylenex recombinant — Class II drug recall D-0116-2025
Terminated recall by Mckesson Medical-Surgical Inc. Corporate Office, reported 2024-12-18. cGMP Deviations: Temperature excursion
| Recall number | D-0116-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA, United States |
| Recall initiated | 2024-09-11 |
| Classified | 2024-12-10 |
| Reported by FDA | 2024-12-18 |
| Terminated | 2025-08-20 |
| Reason classes | cgmp, temperature control |
| NDC | 18657-0117, 18657-0117-01, 18657-0117-02, 18657-0117-04 |
| Serial numbers | 100000820515, 100000820688, 100000820689, 100000831961 |
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 for recall
cGMP Deviations: Temperature excursion
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0116-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.