PHUK Sexual Enhancement Supplement Recalled for Unapproved Active Ingredients
Haute Health, LLC is recalling PHUK Sexual Enhancement Ultimate Pleasure because it may contain unapproved active ingredients found in FDA-approved erectile dysfunction drugs.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Haute Health, LLC is voluntarily recalling PHUK Sexual Enhancement Ultimate Pleasure, a dietary supplement distributed by UME Supplements, INC. The product is packaged in 1 and 2 capsule blister packs and 4, 12, and 24 capsule bottles. The recall affects 172,800 capsules with all lot codes and expiration dates.
The FDA is classifying this as a Class I recall because the dietary supplement was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The product may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED), which makes the dietary supplement an unapproved drug.
The product was distributed nationwide and internationally via internet sales. Consumers who have purchased this product should stop using it and contact the distributor or manufacturer for further instructions.
The recalled product
- Product
- PHUK Sexual Enhancement Ultimate Pleasure, 400mg/capsule, packaged in 1 and 2 capsule blister packs and 4,12,24 capsule bottles, Distributed by UME Supplements, INC www.phukherbal.com.
- Manufacturer
- Haute Health, LLC
- Category
- Drug — Dietary Supplement
- Affected units
- 172,800
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 (1)
- All lot codes and expiration dates.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Haute Health, LLC 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.
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