Elevated risk U.S. Food and Drug Administration

Arize brand male enhancement capsules recall: Products contain undeclared Nortadalafil

Recall published 2+ years ago

Products contain undeclared Nortadalafil

Arize Prescription & OTC drugs — recalled prescription & otc drugsArize Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)
2 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Undeclared allergen or ingredient

The food itself is fine. What is wrong is the label, and for the households that rely on that label it is a real risk.

What the notice says: Risk Statement: Consumption of products with undeclared nortadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may 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
February 2, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Arize
Product type
Prescription & OTC drugs
Reports of harm
To date, no adverse events have been reported.

Products covered by this recall

Arize brand male enhancement capsules

What the company announced

‘The company has issued a correction to the previous announcement’.

FOR IMMEDIATE RELEASE – Feb 2, 2024 - VANCOUVER, WA, “Today The World” is voluntarily recalling one lot of Arize Herbal Dietary Supplement capsules to the consumer level. FDA analysis has found the products to contain undeclared Nortadalafil (structurally similar to Tadalafil). Nortadalafil is an active drug ingredient known for treatment of male erectile dysfunction. The presence of Nortadalafil in Arize makes this an unapproved new drug for which the safety and efficacy has not been established and, therefore subject to recall.

Risk Statement: Consumption of products with undeclared nortadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population, who are most likely to use this product, adult males who use nitrates for cardiac conditions are most at risk. To date, no adverse events have been reported.

This tainted product is marketed as a dietary supplement for male sexual enhancement and is packaged and coded as follows:

Arize: 2107, EXP: 10/2024

The product was distributed via website www.getarize.com in the USA. The product can be identified by –black box with the word Arize written in red on the front with a line underneath which reads: “For a rise that is hard to forget”.

Today The World is notifying its customers of this recall via press release and is arranging for return/replacement etc. of all recalled product. Consumers that have Arize which is being recalled should stop using them. Product can be returned to Today The World, 11954 NE Glisan St # 405 Portland OR 97220 or destroyed. When returning Arize products, include the blister pack foil (with any remaining pills) containing the recalled lot number and receipt/proof of purchase, and your return address.

Consumers with questions regarding this recall can contact “Today The World” by e-mail [email protected] or customers can call: 1-888-767-4889 between the hours of 10 a.m. and 5 p.m. Pacific Standard Time for instructions on the return and refund 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.

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 10/2024

Model or item number

On the rating label, the box or the instruction sheet.

  • 11954 NE

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Allergen

Arize — The food itself is fine. What is wrong is the label, and for the households that rely on that label it is a real risk.

  1. Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.
  2. Warn anyone else who eats from your kitchen, including schools and childminders.
  3. Report any reaction to the FDA so it is recorded against this recall.
  4. If nobody here avoids it, the product is safe to eat; the refund is still available if you would rather return it.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

Remedy named in the notice: Today The World is notifying its customers of this recall via press release and is arranging for return/replacement etc. of all recalled product.

Company contact: Today the World — Consumers: 1-888-767-4889, [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 Arize prescription & otc drugs recalled?

Products contain undeclared Nortadalafil Risk Statement: Consumption of products with undeclared nortadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: best-by date 10/2024; model number 11954 NE. If the code on your package is not on that list, your unit is outside the recall.

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?

The notice says: Today The World is notifying its customers of this recall via press release and is arranging for return/replacement etc. of all recalled product.

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