CLASS II ONGOING Drug recall · Reported 22 May 2024 · FDA Enforcement Report
MethylPREDNISolone Acetate Injectable Suspension recalled
Sagent Pharmaceuticals is recalling MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per (40 mg per mL), mL, distributed nationwide in the US. The recall was initiated on 25 Apr 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-0499-2024
- FDA event ID
- 94486
- Recalling firm
- Sagent Pharmaceuticals, Schaumburg, IL
- Manufacturer
- Sagent Pharmaceuticals
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Apr 2024
- FDA classified
- 15 May 2024
- Reported
- 22 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 25 Apr 2024 | Recall initiated by company | |
| 15 May 2024 | Classified by FDA | +20 days |
| 22 May 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Potential for black particulates in the drug product.
Product as listed by the FDA
MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Potential for black particulates in the drug product.
Which lots are affected?
Lots 5100186, 5100187, 5100188, 5100189, Exp 01/31/2025
Where was it sold?
Nationwide in the USA
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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|---|---|---|---|---|---|
| Drug | CLASS III | Busulfan Injection, 60 mg per (6 mg per mL), mL Single-Dose Vials recalledBusulfan | Sagent Pharmaceuticals | Potency & Assay | Nationwide |
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|---|---|---|---|---|---|
| Drug | CLASS II | methylprednisolone tablets, USP Dosepak, 4 mg recalled by GreenstoneMethylprednisolone | Greenstone | Other | Nationwide |
| Drug | CLASS II | Methylprednisolone acetate Injectable Suspension recalled by Eugia USMethylprednisolone Acetate | Eugia US | Potency & Assay | 4 states |
| 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 |