CLASS II ONGOING Drug recall · Reported 13 Mar 2024 · FDA Enforcement Report
Methylprednisolone acetate Injectable Suspension recalled by Eugia US
Eugia US is recalling Methylprednisolone acetate Injectable Suspension, USP, 400mg per (80mg/mL Multiple-Dose, distributed in Louisiana, Mississippi, Ohio, Tennessee. The recall was initiated on 20 Feb 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-0366-2024
- FDA event ID
- 94075
- Recalling firm
- Eugia US, East Windsor, NJ
- Manufacturer
- Eugia US LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Feb 2024
- FDA classified
- 4 Mar 2024
- Reported
- 13 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 20 Feb 2024 | Recall initiated by company | |
| 4 Mar 2024 | Classified by FDA | +13 days |
| 13 Mar 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications
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
Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-314-01
Where it was distributed
OH, TN, LA, MS
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lot #: 3MA23001, 3MA23002, 3MA23003, Exp 3/31/2025
Where was it sold?
OH, TN, LA, MS
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.
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Other Methylprednisolone recalls
All 69| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | methylprednisolone tablets, USP Dosepak, 4 mg recalled by GreenstoneMethylprednisolone | Greenstone | Other | Nationwide |
| Drug | CLASS II | MethylPREDNISolone Acetate Injectable Suspension recalledMethylprednisolone Acetate | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS III | Methylprednisolone Acetate Injectable Suspension recalled | Amneal Pharmaceuticals of New York | Packaging Defects | Nationwide |
| Drug | CLASS II | Methylprednisolone 12MG IN NS Syringe, steroid recalled | Sentara Infusion Services | Sterility | Nationwide |
| Drug | CLASS II | MethyLPREDNISolone Acetate Injectable Suspension recalled | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |