# FDA recall D-0480-2024

> **Hikma Injectables USA Inc** · Class III · drug recall initiated 2024-04-30.

## Product

Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05

## Reason for recall

Labeling: Wrong Barcode

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0480-2024
- **Recalling firm:** Hikma Injectables USA Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2024-04-30
- **Report date:** 2024-05-08

- **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-0480-2024

## Citation

> AI Analytics. FDA recall D-0480-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0480-2024. Source: US FDA. Licensed CC0.

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