---
title: "Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL,... — FDA record D-0508-2024 | Is It on Recall"
description: "Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine."
url: https://isitonrecall.com/recall/fda-drug-d-0508-2024-phenylephrine-in-0-9-sodium-chloride-injection-preservative-free-100mcg-ml-5ml-syringe-rx-only-hikma/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA drug enforcement

# Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables... — FDA record D-0508-2024

Reported completed

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Apr 29, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
- **Classification**: Class I
- **Recalling firm**: Hikma Injectables USA Inc
- **Quantity**: Not supplied
- **Agency-reported status**: Completed
- **Source record identifier**: D-0508-2024

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0508-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot #: 240310003D, Exp 6/4/2024 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

CO, GA, PA, SD, WA

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Colorado](https://isitonrecall.com/state/colorado/)
- [Georgia](https://isitonrecall.com/state/georgia/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [South Dakota](https://isitonrecall.com/state/south-dakota/)
- [Washington](https://isitonrecall.com/state/washington/)

## Dates in the source

- **Report date**: May 29, 2024
- **Recall initiation date**: Apr 29, 2024
- **Center classification date**: May 23, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0508-2024%22)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [Hikma Injectables USA Inc records](https://isitonrecall.com/brand/hikma-injectables-usa-inc/)