INDIANAPOLIS — Two companies are recalling their dietary supplements because they are contaminated with the active ingredient in the prescription drug Cialis.
The recalls come as the FDA warns companies that selling products containing undisclosed or hidden prescription drugs violates federal law. In early July, the FDA sent warning letters to four companies that sold honey products containing undeclared active ingredients, including sildenafil and tadalafil.
Sildenafil and tadalafil are the active ingredients in Viagra and Cialis, respectively. Their use is restricted under the supervision of licensed healthcare professionals. The FDA has said these undeclared ingredients can interact with nitrates found in some prescription drugs, such as nitroglycerin, and can 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 tadalafil-tinted dietary supplements.
Since the products are listed as dietary supplements, they are regulated by the FDA as foods, not drugs. By law, the FDA does not have the authority to approve the safety and efficacy of dietary supplements or to approve their labeling. It is the company’s responsibility to ensure that its products meet safety standards and do not violate the law.
However, tadalafil and sildenafil products are excluded from the definition of dietary supplements. Their presence renders the products unapproved drugs for which the safety and effectiveness have not been established.
On July 21, the FDA issued a recall for Ultra Supplement LLC’s Sustango capsules. The recall comes after Amazon contacted the company saying lab analysis found the product was contaminated with tadalafil.
The product was marketed as a dietary supplement for male enhancement. They were packed in blisters of 10 units inside a cardboard box. The FDA said the product was sold online nationwide and shipped by Amazon.
Affected boxes include lot DAP272109, Exp. 04/01/26. Anyone with the recalled lot should stop using it. Ultra Supplement is arranging for the return of all recalled products. To date, Ultra Supplement has not received any reports of adverse events associated with the recall.
Anyone with questions about the recall may contact Jyun Kim by phone: (800) 975-7070 or by email at [email protected] Monday through Friday, 9 a.m. to 5 p.m. EST.
Launch Sequence Reminder
On July 26, the FDA issued a recall for Launch Sequence products from Loud Muscle Science, LLC. The recall was initiated after laboratory analysis revealed the product was contaminated with tadalafil.
The products were marketed as dietary supplements for male sexual enhancement. They were sold online and shipped by Amazon. They were also sold in retail stores. The following products are being recalled:
The company did not specify any recall instructions. The FDA recall page lists 631-720-4188 as the phone number for contact and [email protected] as the email.
Anyone who experiences an adverse event, also called a side effect or bad reaction, should report it to their healthcare professional and to the FDA. The FDA says even a single adverse event report can help them identify a potentially unsafe product and possibly remove it from the market.
Adverse reactions or quality issues can be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
- Complete and submit the report on line
- Ordinary mail or fax: Download the form or call 1-800-332-1088 to request a report form, then complete and return to the address on the self-addressed form, or submit by fax to 1-800-FDA-0178
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