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
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
About Hikma Injectables USA Inc
Hikma Injectables USA Inc has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report