REGULATORY INTELLIGENCE·Recall
FDA Class I Recall: Boulla LLC's VitalityXtra Capsules Contain Undeclared Sildenafil and Diclofenac, Lacking NDA/ANDA Approval
Boulla LLC faces a Class I FDA recall (D-0083-2025) for its VitalityXtra Capsules, 500 mg, distributed by VitalityXtra. The product, marketed without an approved NDA/ANDA, contains undeclared sildenafil and diclofenac. This presents significant regulatory and safety risks, demanding immediate action from procurement and regulatory affairs teams to assess supply chain exposure and ensure product integrity.
90-Day Activity