CLASS I Drug recall · Reported 29 May 2024 · FDA Enforcement Report
Phenylephrine in 0.9% Sodium Chloride Injection recalled
Hikma Injectables USA is recalling Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL syringe, distributed in Colorado, Georgia, Pennsylvania, South Dakota, Washington. The recall was initiated on 29 Apr 2024 and the FDA has classified it as Class I.
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-0508-2024
- FDA event ID
- 94522
- Recalling firm
- Hikma Injectables USA, Dayton, NJ
- Classification
- Class I
- Status
- Completed
- Recall initiated
- 29 Apr 2024
- FDA classified
- 23 May 2024
- Reported
- 29 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Cold & Cough Medicine
Timeline
| 29 Apr 2024 | Recall initiated by company | |
| 23 May 2024 | Classified by FDA | +24 days |
| 29 May 2024 | 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
Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Product as listed by the FDA
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
Where it was distributed
CO, GA, PA, SD, WA
Questions about this recall
Why was it recalled?
Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Which lots are affected?
Lot #: 240310003D, Exp 6/4/2024
Where was it sold?
CO, GA, PA, SD, WA
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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.
More recalls from Hikma Injectables USA
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | phenylephrine in 0.9% Sodium Chloride Inj, 1mg per (100 mcg/mL) recalled | Hikma Injectables USA | Sterility | Nationwide |
| Drug | CLASS II | ketamine inj 50 mg recalled by Hikma Injectables USA | Hikma Injectables USA | Sterility | Nationwide |
| 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 II | phenylephrine in 0.9% Sodium Chloride Inj, 1mg per (100 mcg/mL) recalled | Hikma Injectables USA | Sterility | Nationwide |
| Drug | CLASS II | Phenylephrine HCl, 1000 mcg/ Total Volume per syringe, Intravenous recalled | SSM Health Care St. Louis | Sterility | MO |