Exact FDA event identifier

Event 88335

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

Open FDA event record

Event summary

Timeline bucket: July 16, 2021
Product types: Drug
Classifications: Class I
Statuses: Ongoing
Recalling firm wording: Alpha-Tek LLC

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

ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC 8 60003 03770 6. Also manufactured for and distributed by: Alpha Male Plus, Tucson, AZ UPC 8 60003 74518 2 (pouch), UPC 8 60003 74512 0(carton)

D-0001-2022

Recall number: D-0001-2022
Initiated: July 16, 2021
Classification: Class I
Status: Ongoing
Recalling firm: Alpha-Tek LLC
Quantity: Unknown

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of 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 determined the presence of tadalafil

Code information

All lots within expiry

Distribution pattern

Nationwide in the US