Class I โ€” Serious Health Hazard

Serious health hazard โ€” there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free Recalled by Hikma Injectables USA Inc Due to Mislabeling

Date: April 29, 2024
Company: Hikma Injectables USA Inc
Status: Completed
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Hikma Injectables USA Inc directly.

Affected Products

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

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 5 states: CO, GA, PA, SD, WA

Affected (5 states)Not affected

About Hikma Injectables USA Inc

Hikma Injectables USA Inc has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report