Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89606

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

Open FDA event record

Event summary

Timeline bucket
February 10, 2022
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Positive Health

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

RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.

D-0645-2022
Recall number
D-0645-2022
Initiated
February 10, 2022
Classification
Class I
Status
Terminated
Recalling firm
Positive Health
Quantity
5,500 cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Code information

Lot # 48658908, Exp. date 09/09/2023

Distribution pattern

Product was distributed nationwide via the internet through Amazon Marketplace.