Unrated Drug recall · FDA · Published July 16, 2021

Alpha Male+ Chew Strips Recall: Unapproved Tadalafil Risk

FDA recalls Alpha Male+ male enhancer chew strips due to unapproved tadalafil. Products sold in the US may contain unsafe levels of the drug without FDA approval.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0001-2022Drug Alpha-Tek ›

Recall notice

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

Take action

Contact the company

Recalling firmAlpha-Tek LLC3280 E Hemisphere Loop, Suite 190 · Tucson, AZ 85706-5023

✎ GovInfoNow plain-language explainer

The FDA has recalled Alpha Male+ male enhancer chew strips because they contain tadalafil without proper FDA approval. This poses a risk of unintended drug exposure, especially for people using these products without medical supervision. Read more at govinfonow.com/recall/36072-alpha-male-chew-strips-recall-unapproved-tadalafil-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/36072-alpha-male-chew-strips-recall-unapproved-tadalafil-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0001-2022

Cite this page

“Alpha Male+ Chew Strips Recall: Unapproved Tadalafil Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/36072-alpha-male-chew-strips-recall-unapproved-tadalafil-risk. Based on FDA recall #D-0001-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0001-2022%22&limit=1).

The FDA announced on July 16, 2021, that Alpha-Tek LLC voluntarily recalled ALPHA MALE+ Male Enhancer fruit chew strips because they were marketed without an approved New Drug Application and contained undeclared tadalafil. Owners should stop using the product immediately.

How to tell if you have it

ALPHA MALE+ Male Enhancer, fruit chew strips
Distributed by Umbrella Labs
UPC 8 60003 03770 6
UPC 8 60003 74518 2 (pouch)
UPC 8 60003 74512 0 (carton)
All lots within expiry

The hazard

FDA analysis determined the presence of tadalafil in the product. The recall is classified as Class I, indicating a situation where use of the product could cause serious adverse health consequences or death.

Context

GovInfoNow's records show other recent recalls of similar products include StuffbyNainax MR 7 SUPER 700000 Capsules (2025-12-15) and Shoolin Pharma Chem Tadalafil Recall (2026-08-03).

How to tell if you have this one

Check for the product name 'Alpha Male+' on fruit chew strips in foil pouches. UPC 8 60003 03770 6 or 8 60003 74518 2 (pouch) or 8 60003 74512 0 (carton) are associated with this recall. All lots within expiry date are included.

Brand
Alpha-Tek
Product
ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA
Category
Drug

Based on the official FDA remedy

What to do — step by step

Stop Using It Now
Immediately stop using Alpha Male+ male enhancer chew strips as they contain unapproved tadalafil.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 3 months after the firm started it.

Jul 16, 2021Firm started the recall
Oct 4, 2021FDA classified it Class I
Oct 13, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/36072-alpha-male-chew-strips-recall-unapproved-tadalafil-risk">Alpha Male+ Chew Strips Recall: Unapproved Tadalafil Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0001-2022 (July 16, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0001-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.