Hylenex recombinant (hyaluronidase) injection recall
FDA recall D-0116-2025 · initiated Sep 11, 2024
Mckesson Medical-Surgical Inc. Corporate Office recalled Hylenex recombinant (hyaluronidase) injection in Sep 2024 — an FDA Class II recall (D-0116-2025) because cGMP Deviations: Temperature excursion.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
cGMP Deviations: Temperature excursion
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 5 cartons/20 units each carton
Details
- 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
- Recalling company
- Mckesson Medical-Surgical Inc. Corporate Office
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Virgina
- Initiated
- Sep 11, 2024
- FDA report date
- Dec 18, 2024
This recall is linked to a product we cover: Hylenex Recombinant →
Frequently asked
- Was Hylenex recombinant (hyaluronidase) injection recalled?
- Mckesson Medical-Surgical Inc. Corporate Office recalled Hylenex recombinant (hyaluronidase) injection in Sep 2024 — an FDA Class II recall (D-0116-2025) because cGMP Deviations: Temperature excursion. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Hylenex recombinant (hyaluronidase) injection recalled?
- Per the FDA enforcement record, the reason for recall D-0116-2025 was: cGMP Deviations: Temperature excursion
- Is a recalled Hylenex recombinant (hyaluronidase) injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Hylenex recombinant (hyaluronidase) injection are affected?
- Distributed: Virgina. The recall covers these lots — Serial # 100000831961 100000820688 100000820689 100000820515. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0116-2025.