GL Holdings Issues Voluntary Worldwide Recall of Green Lumber Products Due to Presence of Undeclared Tadalafil

This is a reprint of an FDA Alert.

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Company Announcement Date: October 22, 2019
FDA Publish Date: October 22, 2019
Product Type: Drugs
Reason for Announcement: Contains Tadalafil
Company Name: GL Holdings
Brand Name: Green Lumber
Product Description: Dietary supplements for male sexual enhancement

Company Contact Information
Consumers:
GL Holdings
(949) 426-8622
recall@greenlumber.com

Company Announcement
FOR IMMEDIATE RELEASE – Newport Beach, California. GL Holdings is voluntarily recalling six lots of Green Lumber 2-, 4-, and 10-capsule packages purchased on or before August 10, 2019 to the consumer level. FDA analysis has found one lot of Green Lumber distributed between June and August 2019 to be tainted with tadalafil.

Consumption of a product with undeclared tadalafil may pose a risk to consumers who take prescription medications containing nitrates (such as nitroglycerin). The combination of tadalafil and nitrates may lower blood pressure to dangerous levels which can be life threatening. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be the population most likely to be affected. To date, GL Holdings has not received any reports of adverse events related to this recall.

GL Holdings is recalling the lot that tested positive for tadalafil and, out of an abundance of caution, GL Holdings is also recalling all previous lots, thus this recall encompasses all Green Lumber products sold on or before August 10, 2019. Tadalafil is an FDA approved drug for the treatment of erectile dysfunction. The presence of tadalafil in the Green Lumber products renders them unapproved drugs for which safety and efficacy have not been established, and therefor subject to recall.

The Green Lumber product is marketed as dietary supplements for male sexual enhancement and is packaged in 2-, 4-, and 10-capsule blister packs.

The Green Lumber lot that tested positive for tadalafil was sold between June 10 and August 10, 2019. Some of the blister packs are marked with “XC06 EXP 06/2022.” It is sold in a white wrapper with a green Green Lumber logo on the front and has one of the following UPC codes:

• 2 pack: X0020TSV4R
• 4 pack: X0020TRRHJ
• 10 Pack: X0020TUJLZ

Other lots that are being recalled were sold between April 1, 2018 and June 10, 2019 and may have a different UPC code on the package. Some of these blister packages are marked with one of the following “XC12EXP12/2020,” “XC06EXP06/2021,” “XC10EXP10/2021,” “XC02EXP02/2022,” or “XC04EXP04/2022.”

Images of these packages are included below so that they may be more easily identified by consumers.

This product was distributed in the United States and Canada via internet sales.

GL Holdings is notifying its distributors and customers by email and is arranging for replacement of recalled products, at the request of the customer. Consumers with questions regarding this recall can contact GL Holdings via email at recall@greenlumber.com at any time or by phone at 949-426-8622 on Monday through Friday between the hours of 9 a.m. to 5 p.m. Pacific Time.

Consumers who purchased the product should stop consuming it and return any unused product to GL Holdings. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.