FDA Recalls Weight Loss Capsules Containing Undeclared Sibutramine and Phenolphthalein
Lucy's Weight Loss is recalling Shorts on The Beach Strong Formula capsules nationwide because they contain undeclared sibutramine and phenolphthalein.
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 per the rubric mandates a score of 5 (Critical) regardless of other factors.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Shorts on The Beach Strong Formula by Pink Bikini capsules, 750 mg, packaged in 30-count plastic bottles. The product is manufactured and distributed by Lucy's Weight Loss System (dba. Waisted With Lucy) in Arlington, Texas. The recall covers all lots and is distributed nationwide.
The recall is being conducted because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the product contains undeclared sibutramine and phenolphthalein. These substances are not approved for use in dietary supplements and may pose health risks.
Consumers who have purchased this product should stop using it immediately. They should contact the manufacturer for further instructions on how to return the product or obtain a refund.
The recalled product
- Product
- Shorts on The Beach Strong Formula by Pink Bikini capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010
- Manufacturer
- Lucy's Weight Loss (dba. Waisted With Lucy)
- 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
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Lucy's Weight Loss (dba. Waisted With Lucy) 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 3 products in this recall →Related recalls
Same manufacturer · Lucy's Weight Loss (dba. Waisted With Lucy)
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FDA (Drugs) · 2016-06-01
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- CriticalFDA Recalls Weight Loss Product Containing Undeclared Sibutramine and Phenolphthalein
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- CriticalPink Bikini Strong Formula capsules recalled for undeclared ingredients
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