FDA Recall D-0299-2026

Greenstone Llc · Peapack, NJ

Class II Ongoing 119 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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: Lot # LG7675, Exp. Date Nov 2026

Quantity: 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.

Recall record

Recall number: D-0299-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the United States
Recall initiated: 2026-01-15
Classified by FDA Center: 2026-01-28
FDA published: 2026-02-04
Recalling firm: Greenstone Llc
Firm location: Peapack, NJ

Drug identification

Brand name(s): METHYLPREDNISOLONE
Generic name(s): METHYLPREDNISOLONE
Manufacturer(s): Mylan Pharmaceuticals Inc.
NDC(s): 59762-0049, 59762-4440, 59762-0050, 59762-0051
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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