Changeflow GovPing Government General Class I Recall: MR. 7 Super Capsules Contain Un...
Urgent Enforcement Amended Final

Class I Recall: MR. 7 Super Capsules Contain Undeclared Sildenafil and Tadalafil

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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.

Published by FDA on changeflow.com . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

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, 2026

GovPing 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

Sources: openFDA · Raw JSON

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Last updated

Classification

Agency
FDA
Filed
March 18th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
D-0397-2026

Who this affects

Applies to
Drug manufacturers Healthcare providers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug recall response Market withdrawal
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Product Safety Consumer Protection

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