Quick answers
- What is Methylprednisolone used for?
- The FDA-approved label (Medrol, Pharmacia & Upjohn Company LLC, November 14, 2025) says: “MEDROL Tablets are indicated in the following conditions: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Methylprednisolone have a boxed warning?
- No. None of the 63 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Methylprednisolone?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Methylprednisolone been recalled?
- FDA enforcement reports list 9 recalls of products of this medicine; the newest started January 15, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Methylprednisolone?
- 38 companies list prescription products of Methylprednisolone in the FDA NDC Directory, including Pharmacia & Upjohn Company LLC, Remedyrepack Inc. and Chartwell RX, LLC.
What Methylprednisolone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
MEDROL Tablets are indicated in the following conditions: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). …
— FDA label: Medrol, Pharmacia & Upjohn Company LLC, effective November 14, 2025. Read the full label on DailyMed →
The FDA has 63 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 63 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Injection, powder, for solution · Injection, powder, lyophilized, for solution · Injection |
|---|---|
| Route | Intravenous · Intramuscular · Oral · Intravascular |
| Prescription products | 105 in the FDA NDC Directory |
| Brand names | Solu-Medrol, 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 16 mg tablet | Generic | $1.48 per tablet |
| methylprednisolone 2 mg tablet | Brand: Medrol | $1.57 per tablet |
| methylprednisolone 32 mg tablet | Generic | $2.55 per tablet |
| methylprednisolone 4 mg tablet | Generic | $0.1162–$0.1441 per tablet 12 packages, lowest to highest |
| methylprednisolone 4 mg tablet | Brand: Medrol | $0.2454–$0.2916 per tablet 2 packages, lowest to highest |
| methylprednisolone 8 mg tablet | Generic | $0.9234 per tablet |
| methylprednisolone sodium succinate 125 mg injection, powder, for solution | Generic | $3.27 per unit |
| methylprednisolone sodium succinate 125 mg/2 mL injection | Generic | $3.27 per unit |
| methylprednisolone sodium succinate 125 mg/2 mL injection, powder, for solution | Brand: Solu-Medrol | $10.04 per unit |
| methylprednisolone sodium succinate 125 mg/2 mL injection, powder, lyophilized, for solution | Generic | $3.27 per unit |
| methylprednisolone sodium succinate 40 mg/mL injection, powder, for solution | Brand: Solu-Medrol | $6.28 per unit |
NADAC list of November 4, 2026; these prices took effect between August 19, 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 LLC14 products
- Remedyrepack Inc.6 products
- Chartwell RX, LLC5 products
- Tianjin Kingyork Pharmaceuticals Co., Ltd5 products
- Hikma Pharmaceuticals USA Inc.5 products
- Mylan Pharmaceuticals Inc.4 products
- Zydus Lifesciences Limited4 products
- Zydus Pharmaceuticals USA Inc.4 products
- HF Acquisition Co LLC, DBA HealthFirst4 products
- Eugia US LLC4 products
- Cardinal Health 107, LLC4 products
- Dr. Reddy's Laboratories Inc.4 products
- A-S Medication Solutions3 products
- Proficient Rx LP3 products
- Advanced Rx Pharmacy of Tennessee, LLC3 products
- Bryant Ranch Prepack3 products
- Medical Purchasing Solutions, LLC3 products
- Fresenius Kabi USA, LLC3 products
- Sportpharm LLC2 products
- NuCare Pharmaceuticals, Inc.2 products
- Asclemed USA, Inc.2 products
- Henry Schein, Inc.2 products
- Civica, Inc.2 products
- ProPharma Distribution2 products
- Amneal Pharmaceuticals LLC2 products
- Tianjin Tianyao Pharmaceuticals Co., Ltd.1 product
- PD-Rx Pharmaceuticals, Inc.1 product
- St. Mary's Medical Park Pharmacy1 product
- BluePoint Laboratories1 product
- Phoenix RX LLC1 product
- Hawaii Repack, Inc.1 product
- Major Pharmaceuticals1 product
- Epic Pharma, LLC1 product
- Doc Rx1 product
- American Health Packaging1 product
- Direct_Rx1 product
- Par Health USA, LLC1 product
- Preferred Pharmaceuticals 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 |
|---|---|---|---|
| NDA011153 MEDROL | Pfizer | October 24, 1957 | 20, latest November 4, 2025 2025: Labeling · 2024: Labeling · 2023: Labeling |
| NDA011856 SOLU-MEDROL | Pharmacia and Upjohn | May 18, 1959 | 47, latest November 4, 2025 2025: Labeling · 2024: Labeling · 2023: Labeling |
Generic approvals (12)
- ANDA040189Jubilant Cadista · October 31, 1997
- ANDA040183Ph Health · December 22, 1998
- ANDA040583Fresenius Kabi USA · July 30, 2004
- ANDA040612Fresenius Kabi USA · August 12, 2004
- ANDA207667Eugia Pharma · December 15, 2015
- ANDA202691Hikma · February 16, 2016
- ANDA207549Amneal · November 9, 2016
- ANDA206751Zydus Pharms · April 23, 2018
- ANDA204072Tianjin Tianyao · May 14, 2018
- ANDA209097Chartwell Rx · February 22, 2019
- ANDA212396Tianjin Kingyork · April 20, 2021
- ANDA203125Hikma · September 26, 2022
Shortage status
The FDA drug shortage list does not show these products.
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.
-
January 15, 2026 · Class II · Ongoing · D-0299-2026
Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.
methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton containing 21 Tablets, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977. NDC 59762-4440-2 — Greenstone Llc
-
January 14, 2020 · Class III · Terminated · D-0801-2020
Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.
methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA; Dist by: WEST-WARD, Eatontown, NJ 07724, NDC 0143-9850-01. — Hikma Pharmaceuticals USA Inc.
-
May 6, 2019 · Class II · Terminated · D-1453-2019
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-917-11 — Zydus Pharmaceuticals USA Inc
-
May 6, 2019 · Class II · Terminated · D-1451-2019
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-919-11 — Zydus Pharmaceuticals USA Inc
-
May 6, 2019 · Class II · Terminated · D-1448-2019
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India NDC 68382-916-01 — Zydus Pharmaceuticals USA Inc
-
May 6, 2019 · Class II · Terminated · D-1450-2019
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-918-18 — Zydus Pharmaceuticals USA Inc
-
May 6, 2019 · Class II · Terminated · D-1449-2019
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only, Made in India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-916-34 — Zydus Pharmaceuticals USA Inc
-
October 10, 2014 · Class III · Terminated · D-0043-2015
Subpotent; 6 month stability time point
MethylPREDNISolone Tablets, USP, 4 mg, 100 unit dose blisters, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton of 100 NDC 68084-149-01, Individual Dose NDC 68084-149-11 — American Health Packaging
-
September 11, 2014 · Class III · Terminated · D-1605-2014
Subpotent; 6 month stability time point
MethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21) and b) 21 count blister pack (NDC 0603-4593-15), Rx only, Mfg for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 — Qualitest Pharmaceuticals
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) — Medrol, Pharmacia & Upjohn Company LLC, effective November 14, 2025; 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 →