Exact FDA event identifier

Event 81913

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

Event summary

Timeline bucket: January 08, 2019
Product types: Drug
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Happy Together, 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

5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together Inc., Boynton, FL UPC 649964965644

D-0388-2019

Recall number: D-0388-2019
Initiated: January 08, 2019
Classification: Class I
Status: Terminated
Recalling firm: Happy Together, Inc.
Quantity: N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Marketed without an Approved NDA/ANDA; FDA analysis found product 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; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil

Code information

All lots within expiry

Distribution pattern

Product was sold over the internet