Recall archive / FDA drug enforcement
Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables... — FDA record D-0508-2024
Reported completed
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 29, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- Reason
- Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
- Classification
- Class I
- Recalling firm
- Hikma Injectables USA Inc
- Quantity
- Not supplied
- Agency-reported status
- Completed
- Source record identifier
- D-0508-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot #: 240310003D, Exp 6/4/2024 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
CO, GA, PA, SD, WA
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- May 29, 2024
- Recall initiation date
- Apr 29, 2024
- Center classification date
- May 23, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.