CLASS II Drug recall · Reported 18 Dec 2024 · FDA Enforcement Report
Hylenex recombinant (hyaluronidase) injection recalled
Mckesson Medical-Surgical Inc. Corporate Office is recalling Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, mL Single Dose Vials. The recall was initiated on 11 Sep 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0116-2025
- FDA event ID
- 95830
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA
- Brand
- Hylenex Recombinant
- Manufacturer
- Antares Pharma, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Sep 2024
- FDA classified
- 10 Dec 2024
- Reported
- 18 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 11 Sep 2024 | Recall initiated by company | |
| 10 Dec 2024 | Classified by FDA | +90 days |
| 18 Dec 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP Deviations: Temperature excursion
Product as listed by the FDA
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
Where it was distributed
Virgina
Questions about this recall
Why was it recalled?
cGMP Deviations: Temperature excursion
Which lots are affected?
Serial # 100000831961 100000820688 100000820689 100000820515
Where was it sold?
Virgina
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mckesson Medical-Surgical Inc. Corporate Office
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|---|---|---|---|---|---|
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| Device | CLASS II | Abbott Diagnostics Alinity I Anti-ccps Reagent recalled | Mckesson Medical-Surgical Inc. Corporate Office | Device Malfunction | Nationwide |
Other Hyaluronidase recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hyaluronidase/ml Injection, ml, Sterile, Preserved recalled | The Compounding Pharmacy of America | Sterility | Nationwide |
| Drug | CLASS II | Hyaluronidase/ml Injection, ml, Sterile, Preservative Free recalled | The Compounding Pharmacy of America | Sterility | Nationwide |
| Drug | CLASS II | Hyaluronidase/ml Injection, ml, Sterile, Preserved recalled | The Compounding Pharmacy of America | Sterility | Nationwide |
| Drug | CLASS II | Hyaluronidase, 240 u/mL, injectable glass vial, RX recalled | Oregon Compounding Centers | Sterility | OR, WA |
| Drug | CLASS II | Hyaluronidase Injection, all strengths recalled by FVS Holdings | FVS Holdings | Sterility | Nationwide |