INDIANAPOLIS — Two companies are recalling their dietary supplements because they are tainted with the active ingredient in the prescription drug Cialis.
The recalls come as the FDA is warning companies that selling products that contain undisclosed or hidden prescription medication violates federal law. In early July, the FDA sent warning letters to four companies that sold honey products that contained undeclared active ingredients, including sildenafil and tadalafil.
Sildenafil and tadalafil are the active drug ingredients found in Viagra and Cialis, respectively. They are restricted to use under the supervision of licensed health care professionals. The FDA said these undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels.
Since that warning, several companies have recalled their products for containing undisclosed sildenafil or tadalafil. The latest products are two dietary supplements that are tainted with tadalafil.
Because the products are listed as dietary supplements, they are regulated by the FDA as food, not drugs. Under the law, the FDA does not have the authority to approve dietary supplements for safety and effectiveness or approve their labeling. It is the responsibility of the company to make sure its products meet safety standards and are not violating the law.
However, tadalafil and sildenafil products are excluded from the dietary supplement definition. Their presence makes the products unapproved drugs for which safety and efficacy have not been established.
On July 21, the FDA published a recall for Ultra Supplement LLC’s Sustango capsules. The recall comes after Amazon contacted the company saying laboratory analysis found the product was tainted with tadalafil.
The product was marketed as a dietary supplement for male enhancement. They were packaged in 10-count blisters inside a carton. The FDA said the product was sold online nationwide and fulfilled by Amazon.
The affected cartons include Lot DAP272109, Exp. 4/1/26. Anyone with the recalled lot should stop using it. Ultra Supplement is arranging for the return of all recalled products. So far, Ultra Supplement has not received any reports of adverse events associated with the recall.
Anyone with questions about the recall can contact Jyun Kim by phone number: (800) 975-7070 or e-mail at UltraSupplementLLC@gmail.com Monday through Friday 9 AM – 5 PM EST.
Launch Sequence recall
On July 26, the FDA published a recall for Loud Muscle Science, LLC’s Launch Sequence products. The recall was initiated after laboratory analysis found the product was tainted with tadalafil.
The products were marketed as dietary supplements for male sexual enhancement. They were sold online and fulfilled by Amazon. They were also sold in retail stores. The following products are subject to recall:
The company did not specify recall instructions. The FDA recall page lists 631-720-4188 as a phone number for the contact and firstname.lastname@example.org as an email.
Anyone who experiences an adverse event, also known as a side effect or bad reaction, should report it to their health care professional and FDA. The FDA says even a single adverse event report can help them identify a potentially dangerous product and possibly remove it from the market.
Adverse reactions or quality problems may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178