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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 5,500
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.
Part of a larger recall action
This product is one of 3 recalled by Today The World under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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