Methylprednisolone Acetate

Methylprednisolone Acetate recalls: 5 FDA reports

Recalls involving Methylprednisolone Acetate. What was wrong with each batch, and how the FDA graded the risk.

5Reports
0Class I
2Ongoing
2024-05-22Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

ClassReports
Class II4
Class III1

By year reported

YearReports
20141
20222
20242
Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose V

D-0499-2024  ·  Class II  ·  reported 2024-05-22  ·  Ongoing

Why it was recalled
Presence of Particulate Matter: Potential for black particulates in the drug product.
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
Where it went
Nationwide in the USA
How much
14,360 vials

Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose Vial, Rx only

D-0366-2024  ·  Class II  ·  reported 2024-03-13  ·  Ongoing

Why it was recalled
Failed Dissolution Specifications
Product
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 went
OH, TN, LA, MS
How much
10,080 vials

Depo-Medrol (methylprednisolone acetate injectable suspension, USP) 80mg/mL, packaged in a) 1 mL single-dose v

D-1097-2022  ·  Class II  ·  reported 2022-06-15  ·  Terminated

Why it was recalled
cGMP deviations: Temperature abuse
Product
Depo-Medrol (methylprednisolone acetate injectable suspension, USP) 80mg/mL, packaged in a) 1 mL single-dose vial (NDC# 0009-3475-01), b) 25-count box (NDC 0009-3475-03), Rx only, MFG: Pfizer
Where it went
USA nationwide.
How much
177 cartons

Depo-Medrol (methylprednisolone acetate injectable suspension, USP) 40 mg/mL, 1 mL single-dose vial, Rx only,

D-1096-2022  ·  Class II  ·  reported 2022-06-15  ·  Terminated

Why it was recalled
cGMP deviations: Temperature abuse
Product
Depo-Medrol (methylprednisolone acetate injectable suspension, USP) 40 mg/mL, 1 mL single-dose vial, Rx only, MFG: Pfizer, NDC 0009-3073-03
Where it went
USA nationwide.
How much
2 cartons

Depo-Medrol (methylprednisolone acetate injectable suspension USP), 40 mg/ mL, 1 mL Single-Dose Vial, Rx only,

D-1537-2014  ·  Class III  ·  reported 2014-08-20  ·  Terminated

Why it was recalled
Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval at 25C/60%RH. The registered specification for pH is 3.0 - 7.0
Product
Depo-Medrol (methylprednisolone acetate injectable suspension USP), 40 mg/ mL, 1 mL Single-Dose Vial, Rx only, Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, New York NY 10017 NDC 0009-3073-03 DEPO-MEDROL methylprednisolone acetate Injectable Suspension USP, 40 mg per mL, 1 mL Single-Dose Vial, Rx ONLY, Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, New York NY 10017, NOVAPLUS is a registered trademark of Novation, LLC NDC 0009-3073-23
Where it went
Nationwide
How much
93,800 vials
Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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