Class I Recall: MR. 7 Super Capsules Contain Undeclared Sildenafil and Tadalafil
Summary
FDA classified a Class I recall of MR. 7 SUPER 700000 capsules distributed by mR. 7. FDA analysis found undeclared sildenafil and tadalafil. All lot codes with expiration date 12/31/2029 are affected. The recall was initiated by the firm on December 15, 2025 and classified by FDA on March 18, 2026.
What changed
FDA classified a Class I recall of MR. 7 SUPER 700000 capsules distributed by mR. 7 after agency analysis confirmed the presence of undeclared active pharmaceutical ingredients sildenafil and tadalafil. The product was marketed without an approved New Drug Application or Abbreviated New Drug Application. All lot codes with expiration date 12/31/2029 are included in the recall.
Healthcare providers and distributors who received this product should verify their inventories against the recall and follow standard FDA recall procedures. Consumers who have purchased MR. 7 SUPER capsules should discontinue use and contact their healthcare provider if they have experienced any adverse events.
Archived snapshot
Apr 16, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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Drug Recalls (Class I)
← All Drug Recalls (Class I) Class I D-0397-2026 · 20260311 · Ongoing · Voluntary: Firm initiated
Product
MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7
Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
Affected Lot Numbers / Codes
All codes; Exp 12/31/2029
Quantity
4
Firm Notification Method
Press Release
Distribution
Product was distributed to 4 customers in the US.
Initiated
20251215
FDA Classified
20260318
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