Elevated risk U.S. Food and Drug Administration

THE BEAST capsules recall: Contains undeclared sildenafil

Recall published 7+ years ago

Contains undeclared sildenafil

The Beast Dietary supplements — recalled dietary supplements
Photo published by U.S. Food and Drug Administration with the recall notice.

The hazard: Undeclared allergen or ingredient

An ingredient subject to mandatory disclosure was left off the packaging, which is what the agency classes as misbranding.

What the notice says: Consumption of a product with undeclared PDE-5 inhibitors may pose a threat to consumers because the active ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels which can be life threatening.

Why it matters: An ingredient that U.S. law requires to be declared is present but missing from the label. People who avoid that ingredient cannot make a safe choice from the packaging.

Symptoms and when to call a doctor

An undeclared allergen is a danger only to people allergic or intolerant to that ingredient. For everyone else the food is safe. Reactions range from an itchy mouth, hives, stomach cramps or vomiting through to anaphylaxis — swelling of the lips, tongue or throat, a tight chest, wheezing, a sudden drop in blood pressure or collapse. If anaphylaxis is suspected, use an epinephrine auto-injector straight away and call 911, even if the symptoms seem to settle, because a second wave can follow hours later.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
May 6, 2019
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
The Beast
Product type
Dietary supplements
Distribution
Nationwide

Products covered by this recall

THE BEAST capsules

What the company announced

STIFF BOY LLC. is voluntarily recalling all lots within expiry of The Beast capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil. Sildenafil is an FDA approved drug for the treatment of male erectile dysfunction and is in a class of drugs called phosphodiesterase (PDE-5) inhibitors.

The presence of sildenafil in THE BEAST Capsules renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

Consumption of a product with undeclared PDE-5 inhibitors may pose a threat to consumers because the active ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels which can be life threatening. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be the population most likely to be affected. To date, STIFF BOY LLC. has not received any reports of adverse events related to this recall.

The product is marketed as a dietary supplement for male enhancement and is packaged in blue wrapping and blue box with an image of a beast, 4 capsules per package with no UPC barcode. All lots within expiry are being recalled. Product was distributed nationwide in the USA to online customers.

STIFF BOY LLC is notifying its customers by email and is arranging for return of all recalled products.

Consumers that have product which is being recalled should stop using it immediately and return to the place of purchase.

Consumers with questions regarding this recall can contact STIFF BOY LLC by calling (914)281-4059 or e-mail [email protected] 7 days of the week from 9am and 5pm, Eastern Standard Time, for instructions on the disposition process.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

What to do about Allergen

The Beast — An ingredient subject to mandatory disclosure was left off the packaging, which is what the agency classes as misbranding.

  1. Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.
  2. If nobody here avoids it, the product is safe to eat; the refund is still available if you would rather return it.
  3. If someone does avoid it, stop serving it and check anything already cooked with it.
  4. Warn anyone else who eats from your kitchen, including schools and childminders.

Refunds, and what else you can claim

The purchase price is the floor, not the ceiling. Where a recall caused you a real cost, say so.

  • Claim the refund at the store first; it is the fastest route and needs the least paperwork.
  • If you bought several packs over time, list them. Firms routinely settle for more than a single unit when a customer asks.
  • Medical costs, lost earnings or a spoiled event are not handled at the service desk. Write to the company contact on this page instead, with dates and documents.
  • Keep copies of everything you send. If a recall caused harm, that file is what any later claim rests on.

Company contact: STIFF BOY, LLC — Consumers: Sidney Crawford, 914-281-4059, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was The Beast dietary supplements recalled?

Contains undeclared sildenafil Consumption of a product with undeclared PDE-5 inhibitors may pose a threat to consumers because the active ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels which can be life threatening.

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Company recall announcements record, and contact the company if you are unsure.

What should I do with it right now?

Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.

Can I get my money back?

Claim the refund at the store first; it is the fastest route and needs the least paperwork.

Where was the recalled product sold?

It was distributed nationwide.

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