USA Far Ocean Group announced a voluntary nationwide recall of its supplement products X-Hero and Male Enhancer. FDA lab analysis found samples of X-Hero contained undeclared sulfosildenafil, an analog of sildenafil, and samples of Male Enhancer contained undeclared tadalafil. Sildenafil and tadalafil are FDA-approved drugs indicated for the treatment of erectile dysfunction. Both X-Hero and Male Enhancer pose a threat to consumers because they may interact with nitrates found in some prescription drugs (eg, nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
The following products and package sizes are being recalled:
- X-Hero with English label – 10 capsules, UPC 689087070995
- X-Hero with English label – 8 capsules, UPC 689076499255
- X-Hero with English label – 1 capsule pack
- X-Hero with Chinese/English label – 8 capsules, UPC 689076499255
- Male Enhancer – 60 capsules, UPC 982010061205
Consumers who have X-Hero or Male Enhancer in their possession should stop using it immediately and contact their healthcare provider if they experience any adverse effects that may be related to taking these products.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm248814.htm.