Dexamethasone Sodium Phosphate injection USP — Class II drug recall D-0555-2024
Ongoing recall by Eugia US LLC, reported 2024-06-26, distributed nationwide. Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results
| Recall number | D-0555-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Eugia US LLC, East Windsor, NJ, United States |
| Recall initiated | 2024-05-23 |
| Classified | 2024-06-14 |
| Reported by FDA | 2024-06-26 |
| Distributed | Nationwide (US) |
| Quantity | 70,125 vials |
| Reason classes | specification failure |
| NDC | 55150-0237, 55150-0237-01, 55150-0238, 55150-0238-05, 55150-0239, 55150-0239-30 |
| Lot numbers | 3DS23001, 3DS23004, 3DS23009, 3DS23011 |
| Expiration dates | 2024-06-30, 2024-07-31 |
Product
Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, Made in India, NDC 55150-239-30
Reason for recall
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
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-0555-2024. 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.