# FDA recall D-0116-2025

> **Mckesson Medical-Surgical Inc. Corporate Office** · Class II · drug recall initiated 2024-09-11.

## 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 for recall

cGMP Deviations: Temperature excursion

## Distribution

Virgina

## Key facts

- **Recall number:** D-0116-2025
- **Recalling firm:** Mckesson Medical-Surgical Inc. Corporate Office
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-09-11
- **Report date:** 2024-12-18
- **Termination date:** 2025-08-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Richmond, VA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0116-2025

## Citation

> AI Analytics. FDA recall D-0116-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0116-2025. Source: US FDA. Licensed CC0.

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