CLASS I Drug recall · Reported 5 Feb 2014 · FDA Enforcement Report
Hydravax High Potency Diuretic Weight Loss Solution recalled
IQ Formulations is recalling Hydravax High Potency Diuretic Weight Loss Solution, Pharmaceutical Grade per, Dietary, distributed nationwide in the US. The recall was initiated on 4 Nov 2013 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1050-2014
- FDA event ID
- 66965
- Recalling firm
- IQ Formulations, Sunrise, FL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 4 Nov 2013
- FDA classified
- 30 Jan 2014
- Reported
- 5 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
Timeline
| 4 Nov 2013 | Recall initiated by company | |
| 30 Jan 2014 | Classified by FDA | +87 days |
| 5 Feb 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed Without an Approved NDA/ANDA; this product is being recalled for containing an undeclared diuretic called Triamterene, an FDA approved prescription only medication used to treat edema, making it an unapproved new drug
Product as listed by the FDA
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
Where it was distributed
Nationwide, Hawaii and Puerto Rico
Questions about this recall
Is Hydravax High Potency Diuretic Weight Loss Solution, Pharmaceutical Grade per, Dietary recalled?
Yes. IQ Formulations recalled Hydravax High Potency Diuretic Weight Loss Solution, Pharmaceutical Grade per, Dietary on 4 Nov 2013. The recall is Class I and its status is Terminated. Recall number D-1050-2014.
Why was it recalled?
Marketed Without an Approved NDA/ANDA; this product is being recalled for containing an undeclared diuretic called Triamterene, an FDA approved prescription only medication used to treat edema, making it an unapproved new drug
Which lots are affected?
ALL LOTS
Where was it sold?
Nationwide, Hawaii and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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