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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82758

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

Open FDA event record

Event summary

Timeline bucket
April 23, 2019
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
D.B.P. Distribution

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

Titanium 4000, capsule, 4000 mg, 1 count blister card, 30 blister display boxt, distributed by Titanium 4000 UPC 86077000020

D-1292-2019
Recall number
D-1292-2019
Initiated
April 23, 2019
Classification
Class I
Status
Terminated
Recalling firm
D.B.P. Distribution
Quantity
unknown

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Marketed without an approved NDA/ANDA: 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: undeclared sildenafil and tadalafil.

Code information

Expiration 12/29/2020

Distribution pattern

Nationwide.