Class II · ModerateRecall completed
phenylephrine in 0.9% Sodium Chloride Inj
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot number: 243120003D, Use by Date: 03/11/2025
Where it was soldNationwide in the USA
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
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
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 | 63037-173-25 |
Show the full FDA record
| Full product label | phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25 |
| Recalling firm | Hikma Injectables USA Inc |
| Distribution | Nationwide in the USA |
| Recall initiated | 2024-12-19 |
| Report date | 2025-01-08 |
| Recall completed | 2025-11-12 |
| Recall number | D-0174-2025 |
| Classification | Class II |
| FDA status | Terminated |
| 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.