Ultra ZX Dietary Supplement Recalled for Undeclared Sibutramine and Phenolphthalein
Ultra ZX Labs is recalling Ultra ZX dietary supplements because FDA testing found undeclared sibutramine and phenolphthalein. The product was marketed without an approved NDA or ANDA.
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 source text explicitly states the agency classification is Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Ultra ZX Labs, L.L.C. is recalling 636 bottles of Ultra ZX dietary supplements. The product contains Extracto de Naranjo Amargo 70, Extracto de semilla de Sen 47.6, Lagrima de Coix 42, and Almidon Medico 84. The recall was initiated because FDA laboratory analysis confirmed the presence of undeclared sibutramine and phenolphthalein in the product.
The agency classified this as a Class I recall because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The distribution of the affected units included nationwide locations in the United States, Puerto Rico, and foreign markets in Spain and Ecuador.
Consumers who possess this product should stop using it immediately. The source text does not provide specific instructions for disposal or return, but the presence of undeclared pharmaceutical ingredients poses a significant health risk.
The recalled product
- Product
- ULTRA ZX DIETARY SUPPLEMENT (Extracto de Naranjo Amargo 70, Extracto de semilla de Sen 47.6, Lagrima de Coix 42, Almidon Medico 84), 30 capsule bottles, Manufactured and distributed by: Ultra ZX Labs, L.L.C. 2525 SW 3rd Ave Apt 1704 Miami, Florida 33129-2068.
- Manufacturer
- Ultra ZX Supplements
- Category
- Drug — Dietary Supplement
- Affected units
- 636
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/codes/bottles/packages.
Distribution
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