LaBri's Body Health XPLODE Recalled for Unapproved Sibutramine
EZWeightLossTX LLC is recalling LaBri's Body Health XPLODE capsules because they contain sibutramine, an unapproved drug ingredient.
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 FDA classifies this as a Class I recall, which meets the rubric criteria for a Critical severity score (5).
Plain-English summary
EZWeightLossTX LLC is voluntarily recalling 1,424 bottles of LaBri's Body Health XPLODE 30 capsules. The product was marketed as a dietary supplement but was found to be tainted with sibutramine, making it an unapproved drug. The recall covers all lots remaining within their expiration dates and was distributed nationwide.
The FDA classifies 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 The presence of sibutramine, a controlled substance previously withdrawn from the market due to safety concerns, renders the product an unapproved drug rather than a dietary supplement.
Consumers who have purchased LaBri's Body Health XPLODE capsules should stop using the product immediately. They should contact EZWeightLossTX LLC for a refund or further instructions. The recall is nationwide, and all remaining stock within the expiration date is affected.
The recalled product
- Product
- LaBri's Body Health XPLODE 30 capsules Exclusively distribute worldwide by LaBri's Body Health.
- Manufacturer
- EZWeightLossTX LLC
- Category
- Drug — Dietary Supplement
- Affected units
- 1,424
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 remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by EZWeightLossTX 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.
See all 2 products in this recall →Related recalls
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See all →- CriticalFDA Recalls LaBri's Body Health Atomic 60 Capsules for Sibutramine Contamination
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