US Drug Recall Register
Class II · Moderate risk Terminated Initiated Sep 11, 2024 (2 years ago)

Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

cGMP Deviations: Temperature excursion

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

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

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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