August 2025 FDA Recall Drug by Green Lumber Holdings, Llc
D-0304-2026 - Marketed without an Approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Green Lumber Holdings, Llc on August 28, 2025 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0304-2026

Reason for Recall
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil
Initiated
08-28-2025
Reported
02-11-2026
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
97526
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Green Lumber Holdings, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# LOT308EXP03/28