Bestherbs Coffee LLC is recalling all lots of 13-gram packages of “New of Kopi Jantan Tradisional Natural Herbs Coffee” because FDA laboratory analysis confirmed the presence of desmethyl carbodenafil, which is similar to the active ingredient in Viagra and can be deadly when combined with nitrates frequently found in heart and blood pressure medications.
The recall comes almost a year after the Food and Drug Administration posted a public notice on Aug. 30, 2016, warning against the same product, reporting it found desmethyl carbodenafil in the beverage mix, which is marketed as a male enhancement product. Bestherbs Coffee LLC distributed this product from July 2014 through June 2016.
No illnesses had been confirmed in relation to the Bestherbs Coffee product as of the posting of the recall on July 13. However, in May a recall notice of a similar product by Caverflo.com reported one death.
New of Kopi Jantan Tradisional Natural Herbs Coffee also contains milk, which is not declared on the packaging as required by federal law. People who have milk allergies or sensitivities and consume this product, are at risk of serious or life threatening reactions, according to the recall notice posted on the FDA website.
The undeclared desmethyl carbodenafil in the coffee could interact with nitrates in other prescription drugs, such as nitroglycerin. It is common for men with diabetes, high blood pressure, high cholesterol or heart disease to be prescribed nitrates. The undeclared drug could lower blood pressure to dangerous levels.
There is concern consumers may have unused portions of the recalled 13-gram, red packs in their homes. To determine if they have the recalled product, consumers should check the box, which contains 25 packets, for the UPC number 557205060083.
“New of Kopi Jantan Tradisional Natural Herbs Coffee is consumed as an instant coffee. New Kopi Jantan Tradisional Natural Herbs Coffee was distributed nationwide to consumers via individuals or internet,” according to the recall notice
Although no illness has been reported to date, the FDA reported that Bestherbs Coffee is continuing to notify its customers of the recall by phone. Consumers are being urged to discard the product immediately and contact their doctor.
This recall is the most recent in a series of warnings and recalls involving coffee products posted by FDA in the past year, specifically because of undeclared erectile dysfunction drugs:
- In September 2016 FDA posted a warning about Stiff Bull brand “Herbal Coffee” because it found undeclared desmethyl carbodenafil while inspecting international mail shipments.
- In May this year Caverflo.com recalled its “Natural Herbal Coffee” after FDA laboratory analysis confirmed the presence of Sildenafil and Tadalafil, which are the active ingredients in two prescription drugs used for the treatment of erectile dysfunction. Caverflo.com has received a report of an individual death after use of the coffee. Caverflo Natural Herbal Coffee may also contain undeclared milk according to the May recall notice.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of such products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online at MedWatch Online Voluntary Reporting Form, or;
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
In its warning notices, the FDA reported “a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals.”
“These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being ‘all natural.’ FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients,” according to the FDA’s notices warning against the coffee products.
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