FDA Recalls Zero Xtreme Fat Burner for Unapproved Ingredients
The FDA is recalling Zero Xtreme High Performance Fat Burner capsules because testing found unapproved ingredients. Consumers should stop using the product.
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
The U.S. Food and Drug Administration (FDA) is recalling Zero Xtreme High Performance Fat Burner capsules, 30-count bottles, distributed by Xtreme Z Distributors, Inc. The recall involves 70,350 capsules from Lot 1220062085 with an expiration date of 09/16. The product was distributed nationwide.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine in the capsules.
Consumers who have purchased this product should stop using it immediately. The source text does not provide specific instructions for disposal or return, nor does it report any illnesses or injuries associated with the product.
The recalled product
- Product
- Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distributed by Xtreme Z Distributors, Inc., Miami, FL 33180
- Manufacturer
- XTREME Z DISTRIBUTORS INC
- Category
- Drug — Dietary Supplement
- Affected units
- 70,350
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 1220062085
- Exp. 09/16
Distribution
Distributed nationwide across the United States.
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