FDA Recalls Hydravax Weight Loss Supplement for Undeclared Prescription Drug
IQ Formulations is recalling Hydravax High Potency Diuretic Weight Loss Solution because it contains an undeclared prescription diuretic, Triamterene.
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
IQ Formulations, LLC is recalling Hydravax High Potency Diuretic Weight Loss Solution, a dietary supplement manufactured and distributed by Metabolic Nutrition. The product is being recalled because it contains an undeclared diuretic called Triamterene. Triamterene is an FDA-approved prescription-only medication used to treat edema, which makes the supplement an unapproved new drug.
The recall covers all lots of the product, which is described as containing 45 capsules per bottle. The product was distributed nationwide, including Hawaii and Puerto Rico.
Consumers should stop using the product and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- Hydravax High Potency Diuretic Weight Loss Solution, Pharmaceutical Grade, 45 capsules per bottle, Dietary Supplement, Manufactured and Distributed by Metabolic Nutrition, Sunrise, Florida, www.metabolicnutrition.com
- Manufacturer
- IQ Formulations, LLC
- Category
- Drug — Dietary Supplement
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 LOTS
Distribution
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