MethylPREDNISolone Acetate Injectable Suspension recall
FDA recall D-0499-2024 · initiated Apr 25, 2024
Sagent Pharmaceuticals recalled MethylPREDNISolone Acetate Injectable Suspension in Apr 2024 — an FDA Class II recall (D-0499-2024) because Presence of Particulate Matter: Potential for black particulates in the drug product.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of Particulate Matter: Potential for black particulates in the drug product.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 14,360 vials
Details
- Product
- 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
- Recalling company
- Sagent
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Apr 25, 2024
- FDA report date
- May 22, 2024
Frequently asked
- Was MethylPREDNISolone Acetate Injectable Suspension recalled?
- Sagent Pharmaceuticals recalled MethylPREDNISolone Acetate Injectable Suspension in Apr 2024 — an FDA Class II recall (D-0499-2024) because Presence of Particulate Matter: Potential for black particulates in the drug product. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was MethylPREDNISolone Acetate Injectable Suspension recalled?
- Per the FDA enforcement record, the reason for recall D-0499-2024 was: Presence of Particulate Matter: Potential for black particulates in the drug product.
- Is a recalled MethylPREDNISolone Acetate Injectable Suspension dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of MethylPREDNISolone Acetate Injectable Suspension are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lots 5100186, 5100187, 5100188, 5100189, Exp 01/31/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0499-2024.