CLASS II ONGOING Drug recall · Reported 26 Jun 2024 · FDA Enforcement Report
Dexamethasone Sodium Phosphate injection USP, 120mg recalled by Eugia US
Eugia US is recalling Dexamethasone Sodium Phosphate injection USP, 120mg per (4mg/mL) Multiple-Dose Vial, distributed nationwide in the US. The recall was initiated on 23 May 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0555-2024
- FDA event ID
- 94685
- Recalling firm
- Eugia US, East Windsor, NJ
- Manufacturer
- Eugia US LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 May 2024
- FDA classified
- 14 Jun 2024
- Reported
- 26 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 23 May 2024 | Recall initiated by company | |
| 14 Jun 2024 | Classified by FDA | +22 days |
| 26 Jun 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Which lots are affected?
Lot#: 3DS23001, 3DS23004, Exp 6/30/2024; 3DS23009, 3DS23011, Exp 7/31/2024
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Eugia US
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Lidocaine HCl Injection, USP 2%, 40 mg recalled by Eugia USLidolog Kit | Eugia US | Other | Nationwide |
| Drug | CLASS II | Gentamicin Injection, USP, (Pediatric), 20 mg recalled by Eugia USGentamicin | Eugia US | Potency & Assay | Nationwide |
| Drug | CLASS II | Tirofiban Hydrochloride Injection 5 mg recalled by Eugia USTirofiban | Eugia US | Potency & Assay | Nationwide |
| Drug | CLASS II | Tirofiban Hydrochloride Injection 12.5 mg recalled by Eugia USTirofiban | Eugia US | Potency & Assay | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Injection, USP, CIII, 200mg per mL recalledTestosterone Cypionate | Eugia US | Manufacturing (CGMP) Deviations | Nationwide |
Other Dexamethasone recalls
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dexamethasone Sodium Phosphate Injection, USP, 100 mg recalledDexamethasone Sodium Phosphate | Somerset Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS II | Dexamethasone 16mg/ML Vial) Injectable recalled by Pharmacy Innovations | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS II | Dexamethasone Elixir, USP 0.5 mg/, Net recalled | Morton Grove Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Dexamethasone sodium phosphate, sterile otic solution recalled | Edge Pharma | Sterility | Nationwide |
| Drug | CLASS II | Dexamethasone (LA) Injectable Suspension recalled | Fusion IV Pharmaceuticals | Sterility | Nationwide |