Class I · Most seriousRecall completed
Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free
A reasonable chance it could cause serious harm or death.
Does this affect you?
Check your lot numberLot #: 240310003D, Exp 6/4/2024
Where it was soldCO, GA, PA, SD, WA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
| Distributed by / for | Hikma Injectables USA Inc |
| NDC | 63037-123-25 |
Show the full FDA record
| Full product label | 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 |
| Recalling firm | Hikma Injectables USA Inc |
| Distribution | CO, GA, PA, SD, WA |
| Recall initiated | 2024-04-29 |
| Report date | 2024-05-29 |
| Recall completed | — |
| Recall number | D-0508-2024 |
| Classification | Class I |
| FDA status | Completed |
| Origin on file | Dayton NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.