# FDA recall D-0174-2025

> **Hikma Injectables USA Inc** · Class II · drug recall initiated 2024-12-19.

## Product

phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25

## Reason for recall

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0174-2025
- **Recalling firm:** Hikma Injectables USA Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-12-19
- **Report date:** 2025-01-08
- **Termination date:** 2025-11-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dayton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0174-2025

## Citation

> AI Analytics. FDA recall D-0174-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-0174-2025. Source: US FDA. Licensed CC0.

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