CLASS II Drug recall · Reported 8 Jan 2025 · FDA Enforcement Report
phenylephrine in 0.9% Sodium Chloride Inj, 1mg per (100 mcg/mL) recalled
Hikma Injectables USA is recalling phenylephrine in 0.9% Sodium Chloride Inj, 1mg per (100 mcg/mL), distributed nationwide in the US. The recall was initiated on 19 Dec 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0174-2025
- FDA event ID
- 95993
- Recalling firm
- Hikma Injectables USA, Dayton, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Dec 2024
- FDA classified
- 2 Jan 2025
- Reported
- 8 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Cold & Cough Medicine
Timeline
| 19 Dec 2024 | Recall initiated by company | |
| 2 Jan 2025 | Classified by FDA | +14 days |
| 8 Jan 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Which lots are affected?
Lot number: 243120003D, Use by Date: 03/11/2025
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 95993This product is part of a recall event; the main page for the event is ketamine inj 50 mg recalled by Hikma Injectables USA.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | ketamine inj 50 mg recalled by Hikma Injectables USA | Hikma Injectables USA | Sterility | Nationwide |
More recalls from Hikma Injectables USA
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | ketamine inj 50 mg recalled by Hikma Injectables USA | Hikma Injectables USA | Sterility | Nationwide |
| Drug | CLASS I | Phenylephrine in 0.9% Sodium Chloride Injection recalled | Hikma Injectables USA | Labeling Errors | 5 states |
| Drug | CLASS III | Fentanyl 1000mcg/ (10mcg/mL) in 0.9% Sodium Chloride Injection recalled | Hikma Injectables USA | Packaging Defects | Nationwide |
Other Phenylephrine recalls
All 122| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Phenylephrine Hydrochloride Injectable Solution, 40mg recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg recalled | Denver Solutions | Sterility | Nationwide |
| Drug | CLASS I | Phenylephrine HCl Injection, USP 100 mg/ (10 mg/mL) vials recalled | Provepharm | Particulate Matter | Nationwide |
| Drug | CLASS I | Phenylephrine in 0.9% Sodium Chloride Injection recalled | Hikma Injectables USA | Labeling Errors | 5 states |
| Drug | CLASS II | Phenylephrine HCl, 1000 mcg/ Total Volume per syringe, Intravenous recalled | SSM Health Care St. Louis | Sterility | MO |