Class I Recall for Male Enhancement Supplements

A Class I recall has been issued for 5 000 boxes of Ram It and To The Moon capsules distributed by Integrity Products after a US Food and Drug Administration (FDA) analysis found the dietary supplements were tainted with sildenafil and tadalafil. 

“Sildenafil/tadalafil is an FDA-approved drug for the treatment of erectile dysfunction,” recalling firm Integrity Products, St. Louis, Missouri, stated in an announcement published by the FDA on June 11, 2024. “[T]he presence of sildenafil in the Ram It & To The Moon products renders them unapproved drugs for which safety and efficacy have not been established.”

According to the July 10, 2024, FDA Enforcement Report, the FDA designated the recall Class I on July 3, 2024. A Class I designation is the FDA’s most serious classification and warns use of the products could cause serious adverse health consequences or death.

“Men with diabetes, high blood pressure, high cholesterol, or heart disease may be on medications that if taken with these products could lower blood pressure to dangerous levels that could be life threatening…” the firm stated. “To date, Integrity Products has not received any reports of adverse events related to this recall.”

The recall includes the following products, which were distributed throughout the United States by Integrity Products, Fenton, Missouri:

• To the Moon Capsules, Horny Goat Weed, 1 000 mg, packaged in a box containing a 10-count blister card, from lot HGW221116/Batch 022123-1 (Exp. 5/31/25); and
• Ram It, Horny Goat Weed, dietary supplement capsules, 1 000 mg, packaged in a box containing a 10-count blister card, from lot HGW221116/Batch 020123-1 (Exp. 5/31/25).

Integrity Products voluntarily initiated the recall on February 1, 2024. 

Ram It and To The Moon capsules are marketed online as dietary supplements for male sexual enhancement.