Male Performance Supplements Recalled for Hidden Drug Ingredients
A Class I recall has been issued for dietary supplements marketed for male performance and energy by Boulla LLC and VitalityVita. The recalls are included in the December 11, 2024, US Food and Drug Administration (FDA) Enforcement Report.
According to the FDA, the products contain undeclared sildenafil, the active ingredient in Viagra, and diclofenac, a nonsteroidal anti-inflammatory drug (NSAID). A Class I recall is the administration’s most significant recall classification and warns use of the affected supplements could cause serious adverse health consequences or death.
The recall affects the following products, which were distributed throughout the United States:
- VitalityXtra capsules, 500 mg, packaged in 10-count blisters, from lot 230811 (Exp. 8/11/25), distributed by VitalityXtra, San Francisco, California;
- PeakMax capsules, 500 mg, packaged in 10-count blisters, from lot 230811 (Exp. 8/11/25), distributed by PeakMax, San Francisco, California;
- ZoomMax capsules, 500 mg, packaged in 10-count blisters, from lot YZM240406 (Exp. 4/5/27), distributed by ZoomMax, Sacramento, California; and
- ZapMax capsules, 500 mg, packaged in 10-count blisters, from lot YZM240406 (Exp. 4/5/27), distributed by ZapMax, Sacramento, California.
Undeclared sildenafil “may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels,” the FDA stated in a November 8, 2024, announcement concerning one of the recalled supplements. “People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.”
Hidden diclofenac, the statement continued, “may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.”
The supplements were sold online via Amazon.com and other websites. Boulla LLC initiated the recalls on November 4, 2024. The FDA designated them Class I on December 2, 2024.
