# FDA recall D-0508-2024

> **Hikma Injectables USA Inc** · Class I · drug recall initiated 2024-04-29.

## Product

Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25

## Reason for recall

Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.

## Distribution

CO, GA, PA, SD, WA

## Key facts

- **Recall number:** D-0508-2024
- **Recalling firm:** Hikma Injectables USA Inc
- **Classification:** Class I
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2024-04-29
- **Report date:** 2024-05-29

- **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-0508-2024

## Citation

> AI Analytics. FDA recall D-0508-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0508-2024. Source: US FDA. Licensed CC0.

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