# FDA recall D-0173-2025

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

## Product

ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office Use Only. NDC 63037-137-25

## 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-0173-2025
- **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-0173-2025

## Citation

> AI Analytics. FDA recall D-0173-2025. Retrieved 2026-09-22 from https://api.ai-analytics.org/recall/D-0173-2025. Source: US FDA. Licensed CC0.

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