REGULATORY INTELLIGENCE·Warning Letter
FDA Class I Recall: StuffbyNainax's MR. 7 SUPER 700000 Capsules Contained Undeclared Sildenafil and Tadalafil
The FDA initiated a Class I recall for StuffbyNainax's MR. 7 SUPER 700000 capsules due to undeclared sildenafil and tadalafil, and marketing without an approved NDA/ANDA. This poses significant health risks and regulatory non-compliance, impacting any downstream distributors and emphasizing stringent supplier vetting for pharmaceutical and supplement businesses.
90-Day Activity
StuffbyNainaxEntropic Labs SARM RAD-140, 20mg Capsules, 30-count bottlesHSN 2933.59HSN 2934.99
MKMeera Krishnan· Senior Regulatory Intelligence Analyst2026-03-11 Warning Letter