Medications & Supplements/Dietary Supplements

ALPHA MALE+ Male Enhancer Recalled for Undeclared Tadalafil

Agency Publication Date: October 4, 2021

Summary

Alpha-Tek LLC is recalling all lots of ALPHA MALE+ Male Enhancer fruit chew strips because they contain tadalafil, an undeclared drug ingredient. Tadalafil is the active medicinal ingredient in some prescription drugs for erectile dysfunction; however, it was not listed on the label of this product. The recalled product was sold in individual foil pouches and cartons distributed nationwide by Umbrella Labs and Alpha Male Plus. No injuries or adverse events have been reported to date.

Risk

The undeclared tadalafil can interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. This poses a significant health risk to consumers with diabetes, high blood pressure, high cholesterol, or heart disease who often take nitrates.

What You Should Do

This recall affects ALPHA MALE+ Male Enhancer fruit chew strips sold in single-strip foil pouches and cartons distributed by Umbrella Labs and Alpha Male Plus.
Check your product for UPC codes 860003037706 (Umbrella Labs), 860003745182 (Alpha Male Plus pouch), or 860003745120 (Alpha Male Plus carton). All lots that have not yet reached their expiration date are included in this recall.
If you have health concerns after using this product, contact your healthcare provider or pharmacist immediately.
Return any unused product to the place of purchase for a refund, throw it away, or contact Alpha-Tek LLC directly for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: ALPHA MALE+ Male Enhancer

Variants: Fruit chew strips, 1 strip per foil pouch, Carton

UPC Codes:

860003037706

860003745182

860003745120

Distributed by Umbrella Labs and Alpha Male Plus. All lots within expiry are affected.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88335

Status: Active

Manufacturer: Alpha-Tek LLC

Sold By: Umbrella Labs; Alpha Male Plus

Manufactured In: United States

Units Affected: Unknown

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

This recall affects ALPHA MALE+ Male Enhancer fruit chew strips sold in single-strip foil pouches and cartons distributed by Umbrella Labs and Alpha Male Plus.

Check your product for UPC codes 860003037706 (Umbrella Labs), 860003745182 (Alpha Male Plus pouch), or 860003745120 (Alpha Male Plus carton). All lots that have not yet reached their expiration date are included in this recall.

If you have health concerns after using this product, contact your healthcare provider or pharmacist immediately.

Return any unused product to the place of purchase for a refund, throw it away, or contact Alpha-Tek LLC directly for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.