Pink Bikini Weight Loss Capsule Recall: Undeclared Drugs
Lucy's Weight Loss recalls Pink Bikini 'Shorts on The Beach' capsules due to undeclared sibutramine and phenolphthalein. Check your bottle.
Stop using this now
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.
Contact the company
What happened, in plain English
Lucy's Weight Loss (dba. Waisted With Lucy) is recalling all lots of 'Shorts on The Beach Strong Formula by Pink Bikini' capsules, 750 mg, sold in 30-count plastic bottles. The product was marketed without an approved New Drug Application or Abbreviated New Drug Application and contains undeclared sibutramine and phenolphthalein. Sibutramine has been withdrawn from the market due to cardiovascular risks, and phenolphthalein is a known carcinogen. Read more at govinfonow.com/recall/43623-lucy-s-weight-loss-dba-waisted-with-lucy-recalls-shorts.
Source Summary by GovInfoNow · govinfonow.com/recall/43623-lucy-s-weight-loss-dba-waisted-with-lucy-recalls-shorts · Updated October 12, 2026 · FDA enforcement record: FDA #D-0880-2016
Cite this page
“Pink Bikini Weight Loss Capsule Recall: Undeclared Drugs.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/43623-lucy-s-weight-loss-dba-waisted-with-lucy-recalls-shorts. Based on FDA recall #D-0880-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0880-2016%22&limit=1).
Why it’s dangerous
The capsules contain undeclared sibutramine, a drug previously withdrawn due to increased risks of heart attack and stroke, and phenolphthalein, which has been banned from over-the-counter laxatives due to cancer concerns. Because the ingredients are not listed on the label, users cannot assess the safety or dosage, leading to potential serious health consequences.
Who’s affected
Consumers who purchased weight loss supplements marketed under the 'Pink Bikini' brand or 'Shorts on The Beach Strong Formula'. Individuals seeking rapid weight loss solutions are most at risk of ingesting undeclared prescription drugs.
How to tell if you have this one
Look for a 30-count plastic bottle containing capsules labeled 'Shorts on The Beach Strong Formula by Pink Bikini', 750 mg. The product was manufactured and distributed by Lucy's Weight Loss System in Arlington, Texas. All lots are included in this recall.
- Brand
Pink Bikini- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0879-2016 | Pink Bikini Strong Formula capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010; All lots | Unknown |
| D-0880-2016 | 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; All lots | Unknown |
| D-0881-2016 | Shorts on The Beach Golden Edition by Pink Bikini, 800 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010; All lots | N/A |
What to do — step by step
Stop taking the capsules
Discontinue use of 'Shorts on The Beach Strong Formula by Pink Bikini' capsules immediately due to the presence of undeclared drugs.
Discard or return the product
The record does not specify a return address or refund process, so consumers should dispose of the product safely or contact the manufacturer for further instructions.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Where was this product sold?
The distribution pattern is listed as nationwide.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0880-2016 (September 23, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0880-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 12, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.