Quick answers
- What is Methylprednisolone acetate used for?
- The FDA-approved label (Depo-Medrol, Pharmacia & Upjohn Company LLC, January 21, 2026) says: “A. FOR INTRAMUSCULAR ADMINISTRATION When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of DEPO-MEDROL Sterile Aqueous Suspension is indicated as follows: Allergic States …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Methylprednisolone acetate have a boxed warning?
- No. None of the 19 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Methylprednisolone acetate?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 21, 2026). Ask your pharmacist about alternatives.
- Has Methylprednisolone acetate been recalled?
- FDA enforcement reports list 5 recalls of products of this medicine; the newest started April 25, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Methylprednisolone acetate?
- 9 companies list prescription products of Methylprednisolone acetate in the FDA NDC Directory, including Pharmacia & Upjohn Company LLC, A-S Medication Solutions and Amneal Pharmaceuticals LLC.
What Methylprednisolone acetate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
A. FOR INTRAMUSCULAR ADMINISTRATION When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of DEPO-MEDROL Sterile Aqueous Suspension is indicated as follows: Allergic States …
— FDA label: Depo-Medrol, Pharmacia & Upjohn Company LLC, effective January 21, 2026. Read the full label on DailyMed →
The FDA has 19 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 19 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, suspension |
|---|---|
| Route | Intralesional · Intramuscular · Soft tissue · Intra-articular · Intrasynovial |
| Prescription products | 27 in the FDA NDC Directory |
| Brand names | Depo-Medrol |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| methylprednisolone acetate 40 mg/mL injection, suspension | Generic | $5.57–$7.49 per mL 5 packages, lowest to highest |
| methylprednisolone acetate 40 mg/mL injection, suspension | Brand: Depo-Medrol | $6.90 per mL |
| methylprednisolone acetate 80 mg/mL injection, suspension | Generic | $11.92 per mL |
| methylprednisolone acetate 80 mg/mL injection, suspension | Brand: Depo-Medrol | $11.65 per mL |
NADAC list of November 4, 2026; these prices took effect between July 22, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Pharmacia & Upjohn Company LLC6 products
- A-S Medication Solutions6 products
- Amneal Pharmaceuticals LLC5 products
- Sagent Pharmaceuticals2 products
- Eugia US LLC2 products
- Sportpharm LLC2 products
- Amneal Pharmaceuticals NY LLC2 products
- Caplin Steriles Limited2 products
- Asclemed USA, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA011757 DEPO-MEDROL | Pfizer | May 27, 1959 | 30, latest November 4, 2025 2025: Labeling · 2024: Labeling · 2023: Labeling |
Generic approvals (5)
- ANDA201835Sagent Pharms Inc · June 27, 2018
- ANDA210043Amneal · May 20, 2019
- ANDA211930Eugia Pharma · April 13, 2023
- ANDA216502Amneal · November 3, 2023
- ANDA220556Caplin · January 26, 2026
Shortage status
Current shortage · updated October 21, 2026 · first posted December 15, 2021
| Product | Depo-medrol, Injection, 80 mg/1 mL (NDC 0009-3475-03) |
|---|---|
| Availability | Limited Availability |
| Reason given | Other |
| Company | Pfizer Inc. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
April 25, 2024 · Class II · Ongoing · D-0499-2024
Presence of Particulate Matter: Potential for black particulates in the drug 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 — Sagent Pharmaceuticals
-
February 20, 2024 · Class II · Ongoing · D-0366-2024
Failed Dissolution Specifications
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 — Eugia US LLC
-
April 13, 2022 · Class II · Terminated · D-1096-2022
cGMP deviations: Temperature abuse
Depo-Medrol (methylprednisolone acetate injectable suspension, USP) 40 mg/mL, 1 mL single-dose vial, Rx only, MFG: Pfizer, NDC 0009-3073-03 — Mckesson Medical-Surgical Inc. Corporate Office
-
April 13, 2022 · Class II · Terminated · D-1097-2022
cGMP deviations: Temperature abuse
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 — Mckesson Medical-Surgical Inc. Corporate Office
-
July 30, 2014 · Class III · Terminated · D-1537-2014
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
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 m — Pfizer Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Depo-Medrol, Pharmacia & Upjohn Company LLC, effective January 21, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →