phenylephrine in 0 — Class II drug recall D-0174-2025
Terminated recall by Hikma Injectables USA Inc, reported 2025-01-08, distributed nationwide. Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon recei
| Recall number | D-0174-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hikma Injectables USA Inc, Dayton, NJ, United States |
| Recall initiated | 2024-12-19 |
| Classified | 2025-01-02 |
| Reported by FDA | 2025-01-08 |
| Terminated | 2025-11-12 |
| Distributed | Nationwide (US) |
| Reason classes | sterility, packaging |
| NDC | 63037-0173-25 |
| Lot numbers | 243120003D |
| Expiration dates | 2025-03-11 |
Product
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
Reason for recall
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
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-0174-2025. 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.