Changeflow GovPing Pharma & Drug Safety Class I Drug Recall: Green Lumber Natural Fuel ...
Urgent Enforcement Added Final

Class I Drug Recall: Green Lumber Natural Fuel For Men

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Filed February 11th, 2026
Detected March 27th, 2026
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Summary

The FDA has initiated a Class I recall (D-0304-2026) for Green Lumber Natural Fuel For Men capsules due to the presence of tadalafil, an undeclared ingredient. The recall is ongoing and was initiated voluntarily by Green Lumber Holdings, LLC.

What changed

The Food and Drug Administration (FDA) has classified a recall (D-0304-2026) as Class I for Green Lumber Natural Fuel For Men capsules, indicating a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. The recall was initiated voluntarily by Green Lumber Holdings, LLC, after FDA analysis found the product to contain tadalafil, which was not declared and means the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

This action requires immediate attention from any entity involved in the distribution or sale of this product. Companies should verify if they possess any of the affected product (LOT308EXP03/28) and take immediate steps to halt distribution and notify the FDA. Consumers who have purchased the product should discontinue use immediately due to the potential health risks associated with undeclared tadalafil. While the recall is voluntary, the Class I classification signifies the highest level of risk, and non-compliance with recall procedures can lead to further enforcement actions by the FDA.

What to do next

  1. Verify inventory for affected product LOT308EXP03/28
  2. Cease distribution of Green Lumber Natural Fuel For Men capsules
  3. Notify the FDA of recall status and actions taken

Source document (simplified)

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"last_updated": "2026-03-18",
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"results": [
{
"status": "Ongoing",
"city": "Corona Del Mar",
"state": "CA",
"country": "United States",
"classification": "Class I",
"openfda": {
},
"product_type": "Drugs",
"event_id": "97526",
"recalling_firm": "Green Lumber Holdings, LLC",
"address_1": "2855 E Coast Hwy Ste 228",
"address_2": "N/A",
"postal_code": "92625-2200",
"voluntary_mandated": "Voluntary: Firm initiated",
"initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
"distribution_pattern": "Nationwide",
"recall_number": "D-0304-2026",
"product_description": "Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLumber.com, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660",
"product_quantity": "N/A",
"reason_for_recall": "Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil",
"recall_initiation_date": "20250828",
"center_classification_date": "20260210",
"report_date": "20260211",
"code_info": "LOT308EXP03/28"
}
]
}

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
FDA
Filed
February 11th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
D-0304-2026

Who this affects

Applies to
Drug manufacturers Consumers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug Labeling Product Safety
Threshold
Class I
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Compliance frameworks
FDA 21 CFR Part 11 GxP
Topics
Product Safety Consumer Protection

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