Nicardipine Hydrochloride Injection — Class II drug recall D-0390-2024
Ongoing recall by Eugia US LLC, reported 2024-03-27, distributed nationwide. Failed Impurities/Degradation Specifications: Out of specification for organic impurities
| Recall number | D-0390-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Eugia US LLC, East Windsor, NJ, United States |
| Recall initiated | 2024-02-20 |
| Classified | 2024-03-19 |
| Reported by FDA | 2024-03-27 |
| Distributed | Nationwide (US) |
| Quantity | 335,940 vials |
| Reason classes | specification failure |
| NDC | 55150-0183, 55150-0183-01, 55150-0183-10 |
| Lot numbers | 2/24, 3/24, 3NC22013, 3NC22014, 3NC22015, 3NC22016, 3NC22017, 3NC22018, 3NC22020, 3NC23002, 7/24 |
Product
Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 NDC 55150-183-10
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
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-0390-2024. 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.