JXK Enterprises, Inc Issues Voluntary Nationwide Recall of Boner Bears Chocolate Due to Undeclared Sildenafil
JXK Enterprises, Inc has initiated a voluntary nationwide recall of Boner Bears Chocolate (Lot #BB21125) after FDA laboratory testing identified the presence of sildenafil, an undeclared active pharmaceutical ingredient used in prescription drugs.
This recall affects JXK Enterprises, Inc, distributors of Boner Bears Chocolate, and compliance officers within the dietary supplement and specialty food industries.
The presence of undeclared pharmaceutical ingredients in a product marketed as a food or supplement constitutes a significant regulatory violation. This suggests a failure in raw material screening or manufacturing controls. For industry professionals, it highlights the FDA's active laboratory surveillance of products marketed for male enhancement and the potential for federal enforcement when such products are found to be adulterated with prescription-strength substances.
Regulatory and QA teams should immediately quarantine affected lot #BB21125. Review supplier qualification programs and consider implementing periodic identity and purity testing for raw materials or finished products marketed as supplements to ensure no undeclared active pharmaceutical ingredients (APIs) are present.
JXK Enterprises, Inc is voluntarily recalling Boner Bears Chocolate, Lot #BB21125, after being notified that FDA laboratory analysis confirmed the presence of sildenafil, an active ingredient in the FDA-approved prescription drug Viagra, which is not declared on the product label.
Open in openFDA / FDA.gov