Methylprednisolone Tablet
FDA Recall NDC 59762-0049
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Methylprednisolone (NDC 59762-0049). A significant event, classified as Class II, was initiated on Jan 15, 2026 by Mylan Pharmaceuticals Inc.. The reported reason for this action was: "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."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
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.
Jan 15, 2026
Feb 04, 2026
3456 cartons
Recall Profile & Regulatory Data
Event ID
98278
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Greenstone Llc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
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
Batch or Lot Expiration Information
Lot# LG7675, Exp. Date Nov 2026
Affected Packages Involved in this Recall
59762-4440-3Product
59762-4440-2Product
59762-0049-1Product
59762-0050-1Product
59762-0051-1Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
