MKS Enterprise LLC is recalling Dose Vital VIP Vital Honey citing the presence of undeclared active pharmaceutical ingredient Tadalafil, the U.S. Food and Drug Administration said.
The FDA last week had warned four companies, including MKS Enterprise, for illegally selling honey-based products with hidden active drug ingredients, including tadalafil and sildenafil.
Tadalafil, which is a phosphodiesterase type-5 or PDE-5 inhibitor, is the active ingredient in an FDA-approved prescription drug, used to treat erectile dysfunction or ED.
The recalled product comes in a black box and contains 12 sachets of 15 grams of honey with different expiration dates stamped on the back side.
The product was sold through the company website, wholesaleonline1.com from March 2022 to July 2022.
The recall was initiated after FDA laboratory analysis confirmed that Dose Vital VIP Vital Honey contains the undeclared active pharmaceutical ingredient Tadalafil.
Tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
However, wholesaleonline1.com has not received any reports of adverse events related to the recall to date.
Consumers who have purchased Vital Honey on wholesaleonline1.com are urged to immediately discontinue use and return the recalled product for a full refund.
The FDA last week also warned Thirstyrun LLC, also known as US Royal Honey LLC; Shopaax.com; and 1am USA Incorporated dba Pleasure Products USA for illegally selling honey-based products with hidden active drug ingredients.
Separately, Loud Muscle Science, LLC last week called back certain Launch Sequence products in the U.S. and Canada for undeclared Tadalafil.
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