Exact FDA event identifier

Event 96328

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

Event summary

Timeline bucket: February 20, 2025
Product types: Drug
Classifications: Class I
Statuses: Ongoing
Recalling firm wording: One Source Nutrition, Inc,

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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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

Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency.

D-0281-2025

Recall number: D-0281-2025
Initiated: February 20, 2025
Classification: Class I
Status: Ongoing
Recalling firm: One Source Nutrition, Inc,
Quantity: a) 300 individually wrapped capsules b) 20 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Marketed without an approved NDA/ANDA: Product found to be tainted with 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: Product found to be tainted with undeclared sildenafil and tadalafil.

Code information

All lots

Distribution pattern

Nationwide in the U.S.A