The Recall Desk
SevereFDA (Drugs)·D-0345-2024·Announced 2024-02-28

Dietary supplement Arize recalled for undeclared pharmaceutical ingredient

Arize Herbal Dietary Supplement contains an undeclared ingredient (nortadalafil), a pharmaceutical used in FDA-approved male sexual enhancement medications, making it an unapproved drug.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This recall is classified as FDA Class I, the highest-risk category. The product contains an undeclared pharmaceutical ingredient, constituting an unapproved drug that poses unknown health risks without medical oversight or proper labeling information.

Plain-English summary

Arize Herbal Dietary Supplement, packaged in 10 capsules per box and distributed nationwide by Natural Herbal Remedies, LLC (Cheyenne, WY), has been recalled due to the presence of undeclared nortadalafil, a pharmaceutical ingredient used in FDA-approved medications.

The FDA determined that the product contains an undeclared pharmaceutical ingredient and is marketed without required approval (NDA/ANDA), making it an unapproved drug. The affected lot is #2107 with an expiration date of 10/31/2024. Approximately 5,500 boxes were distributed.

Consumers who have purchased this product should stop using it immediately and consult their healthcare provider. The undeclared ingredient may interact with other medications or medical conditions. For additional information, contact your healthcare provider or the FDA.

The recalled product

Product
Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Natural Herbal Remedies, LLC, Cheyenne, WY 82001, www.getarize.com
Manufacturer
Today The World
Hazard
  • undeclared-ingredient
  • unapproved-drug

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 2107
  • Exp. Date 10/31/2024.

Distribution

Distributed nationwide across the United States.