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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98256

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 15, 2025
Product types
Drug
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
StuffbyNainax

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7

D-0397-2026
Recall number
D-0397-2026
Initiated
December 15, 2025
Classification
Class I
Status
Ongoing
Recalling firm
StuffbyNainax
Quantity
4

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil

Code information

All codes; Exp 12/31/2029

Distribution pattern

Product was distributed to 4 customers in the US.