Recall notice · FDA Recall Press Releases

GL Holdings: FDA Recall Notice (Oct 22, 2019)

Agency action: Oct 22, 2019Record ID: fda_recall_p-43877602b9921bfe
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What happened

Original notice title

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

From the archived source record

This recall has been completed and FDA has terminated this recall. 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. More Recalls, Market Withdrawals, & Safety Alerts Recalls, Market Withdrawals, & Safety Alerts Recall Resources Enforcement Reports Industry Guidance For Recalls Major Product Recalls 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.

What the official notice says to do

Check the original notice for the instructions that apply to the named product, company, and affected lots.

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Status and source details

Status recorded in the archive
Published recall notice
Source checked
Jul 16, 2026
Record revision
5e1cf65fcd5e

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

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What is affected

Product
Dietary supplements for male sexual enhancement; GL Holdings Issues Voluntary Worldwide Recall of Green Lumber Products Due to Presence of Undeclared Tadalafil
Company
GL Holdings
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.