MKS Enterprise LLC has issued a voluntary recall of Dose Vital VIP Honey over fears of undeclared active pharmaceutical ingredient Tadalafil. The recall was issued on July 18, 2022, and the official recall announcement was published by the Food and Drug Administration on July 19, 2022.
Tadalafil is a phosphodiesterase type-5 inhibitor commonly used to treat erectile dysfunction. The presence of this ingredient in Dose Vital VIP honey without proper labeling presents a severe health risk to consumers, as it can interact with other medications and may cause potentially life-threatening low blood pressure.
The undeclared ingredient can also interact with nitrates found in some of the leading drugs causing dangerously low blood pressure levels in one’s body. Most people suffering from heart disease usually take drugs containing nitrates.
The FDA warned four companies, including MKS Enterprises, for selling honey-based products containing active ingredients such as Sildenafil and Tadalafil.
The Recalled Product
The recalled product is usually packaged in a black box, with each pack containing 12 sachets of 15grams of honey. The sachets have varying expiration dates stamped on the backside.
The affected product was mainly sold through the company’s official website, wholesaleonline1.com, between March 2022 and July 2022. The product recall was initiated after preliminary laboratory tests conducted by FDA revealed that the honey product contained an undeclared active ingredient, Tadalafil.
However, the manufacturer and official distributors have not received any reports of adverse events that may be related to the recall. The FDA is still monitoring the situation and encourages anyone who might have used the recalled product and developed complications to come forward and report.
All consumers who have purchased Vital Honey on wholesaleonline1.com or any other outlet are urged to discontinue use of the product and return the recalled product for a full refund.
Consumers can reach wholesaleonline1.com at 201-206-0501. The phone lines are open from Monday to Friday, 9:00 am to 6:00 pm EDT.
A few weeks ago, the FDA warned US Royal Honey LLC, also known as Thirstyrun LLC, operating online as Shopaax.com, for illegally marketing and selling honey-based products with hidden active ingredients to its customers.
In a separate case, Loud Muscle Science, LLC also recalled certain Launch Sequence products in the United States and Canada for undeclared, active Tadalafil.
Report Adverse Effects to FDA
If you have experienced adverse effects after using the recalled product, you are encouraged to report to FDA’s MedWatch Adverse Event Reporting program online, by fax, or by regular mail.
You can complete and submit your complaint online. For regular mail and fax, be sure to download the complaints form here or call FDA at 1-800-332-1088 and request a reporting form.
Once you have received the reporting form, complete it carefully and return it to the address on the pre-addressed form or submit it to FDA by fax at 1-800-FDA-0178.
