FDA Drug recall D-0116-2025

Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halozy…

• FDA Drug
• Class II
• terminated
• Published 2024-12-18

On 2024-12-18 the FDA classified a Class II recall of Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halozy… by Mckesson Medical Surgical Corporate Office, citing cGMP Deviations: Temperature excursion.

Read the official FDA Drug notice

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

cGMP Deviations: Temperature excursion

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

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• EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 9…
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• BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA
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All Mckesson Medical Surgical Corporate Office recalls

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0116-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.