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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Phenylephrine Injection Syringes Recalled for Label Mix-Up

Agency Publication Date: May 23, 2024
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Summary

Hikma Injectables USA Inc. is recalling one lot of Phenylephrine in 0.9% Sodium Chloride Injection (100mcg/mL, 5mL syringe) because some syringes were mistakenly labeled with the wrong medication. Specifically, syringes containing ephedrine were mislabeled as phenylephrine. If a patient is accidentally given ephedrine when phenylephrine is intended, it can cause severe health complications due to incorrect blood pressure and heart rate management. Healthcare facilities should immediately identify and stop using the affected syringes.

Risk

Administering the wrong medication during a medical procedure can lead to unintended cardiovascular effects, including dangerous changes in blood pressure or heart rate. Because these drugs are used in critical care and surgical settings, a labeling mix-up poses a high risk of patient harm or ineffective treatment.

What You Should Do

  1. This recall affects Phenylephrine in 0.9% Sodium Chloride Injection (100mcg/mL, 5mL syringe) sold under NDC 63037-123-25, which may actually contain ephedrine.
  2. Check your medical supply stock for lot number 240310003D with an expiration date of June 4, 2024 (6/4/2024).
  3. Stop using the recalled product immediately and quarantine any remaining units from this lot.
  4. Contact Hikma Injectables USA Inc. or your distributor to arrange for the return of the affected syringes.
  5. If you have concerns about a patient who may have received this medication, contact your healthcare provider or hospital's clinical supervisor.
  6. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer initiated recall via letter.

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free (100mcg/mL, 5mL syringe)
Variants: 100mcg/mL, 5mL syringe, Preservative Free, Rx only
Lot Numbers:
240310003D (Exp 6/4/2024)
NDC:
63037-123-25

Labeling mix-up where ephedrine syringes were mislabeled as phenylephrine.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94522
Status: Resolved
Manufacturer: Hikma Injectables USA Inc
Sold By: Hospitals; Clinics; Medical distributors
Manufactured In: United States
Distributed To: Colorado, Georgia, Pennsylvania, South Dakota, Washington

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.