Class II · Moderate risk
Lidocaine HCL / Bupivacaine HCL
Lack of Assurance of Sterility
Hylenex recombinant (Hyaluronidase)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviations: Temperature excursion
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
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
Affected NDC
18657-0117-04
Compare with the code on your package — it is the most precise check available.
Drug: Hyaluronidase
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| HYLENEX Recombinant Hyaluronidase NDC 18657-0117 |
(HUMAN RECOMBINANT) 150 [USP'U]/mL | Injection, Solution Subcutaneous |
Antares Pharma, Inc. | Rx |
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- NDC code
- 18657-117-04
- Origin
- VA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0116-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Hyaluronidase recalls
See all
Class II · Moderate risk
LIDOcaine 2%
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCl 30 mg/mL/Hyaluronidase 15 Units/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Hyaluronidase
Lack of Assurance of Sterility
Class II · Moderate risk
S-Hyaluronidase 150u/Ml Inj Soln
Lack of Assurance of Sterility
Other recalls by Mckesson Medical-Surgical Inc. Corporate Office
All 2024 recalls
Class II · Moderate risk
Infuvite Adult
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
Class II · Moderate risk
Medroxyprogesterone Acetate Injectable Suspension
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
Class II · Moderate risk
BENLYSTA (belimumab)
CGMP Deviations; potential temperature excursions due to transit delays
Class II · Moderate risk
Evenity
CGMP Deviations; potential temperature excursions due to transit delays
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