methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton containing 21 Tablets, Rx only, Distributed by:
Summary
The FDA issued a Class II for methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton contain by Greenstone Llc. Reason: Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing infor.
Details
Source
Drug Recall
External ID
D-0299-2026
Action Date
2026-02-04
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot # LG7675, Exp. Date Nov 2026
Quantity Affected: 3456 cartons
Reason for Recall
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.
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-15
Company
Peapack, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 35 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Greenstone Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Greenstone Llc have FDA actions?
This is the only FDA action we have on record for Greenstone Llc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0299-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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