Class I Recall: MR. 7 SUPER 700000 capsules

drug-class-i

Filed December 15th, 2025

Detected March 27th, 2026

Summary

The FDA has initiated a Class I recall for MR. 7 SUPER 700000 capsules, voluntarily recalled by StuffbyNainax due to the undeclared presence of sildenafil and tadalafil. The recall affects approximately 700,000 capsules distributed within the US.

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What changed

The Food and Drug Administration (FDA) has classified a recall initiated by StuffbyNainax as Class I, the most serious type of recall, concerning MR. 7 SUPER 700000 capsules. The recall, identified by recall number D-0397-2026, was voluntarily initiated by the firm due to the undeclared presence of sildenafil and tadalafil, which are active pharmaceutical ingredients not listed on the product's labeling. This poses a significant health risk, particularly to individuals with underlying health conditions or those taking certain medications.

Regulated entities, specifically drug manufacturers and distributors, should be aware of this enforcement action and the potential health risks associated with unapproved or mislabeled drug products. While this is a specific recall event, it highlights the importance of accurate ingredient disclosure and adherence to NDA/ANDA requirements. Consumers who may have purchased this product should cease use immediately and consult with a healthcare professional if they have concerns. The recall affects product distributed to 4 customers in the US, with all codes and expiration dates up to 12/31/2029 impacted.

What to do next

Review product labeling for undeclared active ingredients.
Ensure compliance with NDA/ANDA requirements for all marketed drug products.
Implement robust quality control measures to detect undeclared substances.

Source document (simplified)

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