FDA Recall D-0304-2026

Green Lumber Holdings, LLC · Corona Del Mar, CA

Class I — life-threatening Ongoing 259 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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

Lot / code: LOT308EXP03/28

Quantity: N/A

Reason for recall

Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil

Recall record

Recall number: D-0304-2026
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: Nationwide
Recall initiated: 2025-08-28
Classified by FDA Center: 2026-02-10
FDA published: 2026-02-11
Recalling firm: Green Lumber Holdings, LLC
Firm location: Corona Del Mar, CA

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

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

‹ All recalls