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Priority review Enforcement Amended Final

Green Lumber Recalls Dietary Supplements for Undeclared Tadalafil

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Filed February 13th, 2026
Detected March 12th, 2026
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Summary

Green Lumber Holding, LLC is updating a recall for counterfeit dietary supplements falsely marketed as Green Lumber. The counterfeit products contain undeclared Tadalafil, a prescription drug, posing potential health risks. Consumers are advised to check lot numbers and discontinue use of affected products.

What changed

Green Lumber Holding, LLC has issued an updated consumer alert regarding counterfeit products falsely marketed as genuine Green Lumber, which were found to contain undeclared Tadalafil. This update clarifies the recalled product lot number (LOT308EXP03/28) and follows the FDA's February 9 publication referencing the original recall initiated on August 28, 2025. The company identified an employee who misappropriated packaging and customer information to distribute counterfeit products, leading to the employee's termination and strengthened safeguards.

Consumers are instructed to check their product packaging for the specific counterfeit lot number and immediately discontinue use if identified. They should report suspected counterfeit products to Green Lumber and the FDA. The presence of undeclared Tadalafil poses significant health risks, particularly for individuals taking nitrates or certain heart medications, due to the potential for dangerously low blood pressure. Consumers experiencing adverse effects should seek prompt medical attention.

What to do next

  1. Discontinue use of any Green Lumber product with Lot Number LOT308EXP03/28.
  2. Verify product lot numbers against the legitimate lot numbers provided by Green Lumber.
  3. Report suspected counterfeit products to Green Lumber and the FDA MedWatch program.

Source document (simplified)

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Summary

Company Announcement Date:

February 13, 2026

FDA Publish Date:

February 13, 2026

Product Type: Dietary Supplements Reason for Announcement: Recall Reason Description Undeclared prescription drug-Tadalafil Company Name: Green Lumber Holding, LLC. Brand Name: Brand Name(s) Green Lumber Product Description: Product Description Dietary Supplement

Company Announcement

“The press release issued on 08/28/2025 was updated to clarify the recalled product lot number.”

Costa Mesa, California — February 13, 2026 — Green Lumber Holding, LLC (“Green Lumber”) is issuing an updated consumer alert regarding counterfeit products falsely marketed as genuine Green Lumber products that may pose potential health risks.

This update follows the U.S. Food and Drug Administration’s (FDA) February 9 publication in its Enforcement Report referencing Green Lumber’s original recall, which was initiated on August 28, 2025. The recall was issued in late August 2025 after FDA testing detected tadalafil—an undeclared prescription drug—in products labeled as Green Lumber. Tadalafil is not an ingredient in any authentic Green Lumber product. The February 9 Enforcement Report does not announce a new recall; it reflects publication of the previously announced August 28, 2025, recall.

Following the FDA’s findings, Green Lumber conducted an internal investigation and determined that a company employee had misappropriated legitimate packaging and customer information to distribute counterfeit or adulterated products. That employee has been terminated.

How to Identify the Counterfeit Recalled Product

The counterfeit recalled product bears the Lot Number LOT308EXP03/28 – This is the only lot number being recalled and is not an authentic Green Lumber lot number and was used in connection with counterfeit products. Consumers should not use any product labeled with this lot number, and it should be discarded.

How to Identify Legitimate Green Lumber Products

Authentic Green Lumber products that are presently being distributed bear the following lot numbers and are not the subject of the recall:

  • LOTGL0130151EXP0926
  • GL01EXP09/27
  • LOT GL110725 EXP110727 Packaging differences are illustrated in the image below, which compares genuine and counterfeit blister packs (authentic on left, counterfeit on right).

Health Risks of Counterfeit Products

The counterfeit versions may contain undeclared tadalafil. Because tadalafil is a prescription-only medication, individuals who take nitrates or certain prescription drugs for heart disease, blood pressure, or other conditions may be at risk of life-threatening side effects such as dangerously low blood pressure or other serious adverse events.

What Consumers Should Do

  • Check your packaging: Confirm that your blister packs show one of the following Lot Numbers LOTGL0130151EXP0926; GL01EXP09/27; or GL110725 EXP110727
  • Immediately discontinue use of any product bearing the Lot number LOT308EXP03/28.
  • Report suspected counterfeit product directly to Green Lumber at [phone/email] and to the FDA’s MedWatch Adverse Event Reporting Program.
  • Seek medical care promptly if you experience unexpected side effects after using the mislabeled product. Company Response

“Consumer safety is our number one priority,” said Brett Hales, President. “We acted swiftly after the FDA’s testing identified tadalafil in a product labeled as ours. Our investigation revealed that an employee had been diverting our packaging and customer channels to sell counterfeit goods. That individual has been terminated, and we have strengthened our safeguards to protect customers and ensure this does not happen again.”

Green Lumber has cooperated with the FDA and law enforcement from the beginning to address this matter and protect consumers.

Contact Information

Green Lumber Holding, LLC
Phone: 949.426.8622
Email: consumer-safety@greenlumber.com
Website: www.greenlumber.com/alert

Link to Initial Press Release

Company Contact Information

Consumers: Green Lumber Holding, LLC 949.426.8622 consumer-safety@greenlumber.com

  • ## Content current as of:

02/13/2026

Source

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

Classification

Agency
Food and Drug Administration
Filed
February 13th, 2026
Instrument
Enforcement
Legal weight
Non-binding
Stage
Final
Change scope
Substantive

Who this affects

Applies to
Consumers Food manufacturers
Geographic scope
National (US)

Taxonomy

Primary area
Food Safety
Operational domain
Compliance
Topics
Dietary Supplements Drug Safety Recalls

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