FDA DrugsClass II

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

Publicado: 4 de febrero de 2026ID de Retiro: D-0299-2026Categoría: Medicamentos y FármacosPaís: Estados Unidos
US
PharmaceuticalFDA DrugsUSUS

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

Recalling Firm: Greenstone Llc

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Motivo del Retiro / Peligro

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.

Descripción del Producto e Identificación

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

Additional Source Details

FieldValue
CityPeapack
StateNJ
Openfda › Nui › 1N0000175576
Openfda › Nui › 2N0000175450
Openfda › Upc › 10359762005014
Openfda › Upc › 20359762005113
Openfda › Upc › 30359762444035
Openfda › UniiX4W7ZR7023
Openfda › RouteORAL
Openfda › Spl idbc3419a0-22a3-4eaf-a4f2-3133e9380663
Openfda › Brand nameMETHYLPREDNISOLONE
Openfda › Spl set id22dd75d6-f89a-44f7-8ca6-b64c4e9806dd
Openfda › Package ndc › 159762-4440-3
Openfda › Package ndc › 259762-4440-2
Openfda › Package ndc › 359762-0049-1
Openfda › Package ndc › 459762-0050-1
Openfda › Package ndc › 559762-0051-1
Openfda › Product ndc › 159762-0049
Openfda › Product ndc › 259762-4440
Openfda › Product ndc › 359762-0050
Openfda › Product ndc › 459762-0051
Openfda › Generic nameMETHYLPREDNISOLONE
Openfda › Product typeHUMAN PRESCRIPTION DRUG
Openfda › Substance nameMETHYLPREDNISOLONE
Openfda › Pharm class epcCorticosteroid [EPC]
Openfda › Pharm class moaCorticosteroid Hormone Receptor Agonists [MoA]
Openfda › Manufacturer nameMylan Pharmaceuticals Inc.
Openfda › Application numberNDA011153
Openfda › Is original packagertrue
Event id98278
Address 1100 Route 206 North
Address 2N/A
Code infoLot # LG7675, Exp. Date Nov 2026
Postal code07977
Report date20260204
Product typeDrugs
Product quantity3456 cartons
Reason for recallLabeling: 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.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260115
Initial firm notificationLetter
Center classification date20260128

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Inspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.

2Isolate & Discontinue Use

Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Drugs).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton containing 21 Tablets, Rx only, Distributed...?

Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (FDA Drugs). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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Resumen

  • Empresa ResponsableGreenstone Llc
  • StatusOngoing
  • Nivel de RiesgoClass II
  • DistributionNationwide within the United States
Recall Hazard Severity
High Alert (Class I)
Alerta Oficial de la Agencia

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🚨 SAFETY ALERT: Greenstone Llc - 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

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