Phenylephrine in 0 — Class I drug recall D-0508-2024
Completed recall by Hikma Injectables USA Inc, reported 2024-05-29, distributed in CO, GA, PA, SD, WA. Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
| Recall number | D-0508-2024 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hikma Injectables USA Inc, Dayton, NJ, United States |
| Recall initiated | 2024-04-29 |
| Classified | 2024-05-23 |
| Reported by FDA | 2024-05-29 |
| Distributed | CO, GA, PA, SD, WA |
| Reason classes | labeling |
| NDC | 63037-0123-25 |
| Lot numbers | 240310003D |
| Expiration dates | 2024-06-04 |
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 for recall
Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0508-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.