Greenstone LLC Recalls Methylprednisolone Dosepak Tablets Due to Dosing Labeling Error

Source: FDA · United States

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Greenstone LLC has voluntarily recalled one lot of Methylprednisolone 4 mg Dosepak tablets because incorrect blister foil orientation provides inaccurate dosing instructions to patients.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on February 11, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

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What Happened

Greenstone LLC has initiated a voluntary recall of one lot of Methylprednisolone tablets, USP Dosepak, 4 mg. The recall was prompted by a labeling error involving the incorrect orientation of the blister foil applied to the blister cavities. This manufacturing defect results in incorrect dosing information when a patient follows the directions printed on the foil.

Which Products Are Affected

The recall affects 3,456 cartons of the following product distributed nationwide within the United States:

  • Product Name: Methylprednisolone tablets, USP Dosepak, 4 mg
  • Configuration: 1 Blister Card per Carton containing 21 Tablets
  • NDC (National Drug Code): 59762-4440-2
  • Lot Number: LG7675
  • Expiration Date: Nov 2026
  • UPC: 0359762444035
  • Manufacturer: Mylan Pharmaceuticals Inc.
  • Distributor: Greenstone LLC, Peapack, NJ

What You Should Do

Consumers and healthcare providers should immediately check their supply for Lot # LG7675. If you have the affected product, you should contact your physician or pharmacist regarding the correct dosing schedule or to obtain a replacement. Patients should not follow the dosing instructions printed on the blister foil of the affected lot. For further information, consumers may contact the recalling firm, Greenstone LLC, based in Peapack, New Jersey.

Why This Matters

This recall is significant because the incorrect orientation of the foil leads to inaccurate dosing instructions. Following incorrect directions for a prescription corticosteroid could result in a patient receiving the wrong dose, potentially leading to ineffective treatment or adverse health consequences.

Source

Information provided by the U.S. Food and Drug Administration (FDA). Recall Number: D-0299-2026.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Greenstone LLC has voluntarily recalled one lot of Methylprednisolone 4 mg Dosepak tablets because incorrect blister foil orientation provides inaccurate dosing instructions to patients.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.