CLASS I Drug recall · Reported 1 Jun 2016 · FDA Enforcement Report
Pink Bikini capsules, (all colors and all strengths) recalled
Lucy's Weight Loss ( is recalling Pink Bikini capsules, (all colors and all strengths), distributed nationwide in the US. The recall was initiated on 9 Dec 2015 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0882-2016
- FDA event ID
- 72820
- Recalling firm
- Lucy's Weight Loss (, Arlington, TX
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 9 Dec 2015
- FDA classified
- 26 May 2016
- Reported
- 1 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
Timeline
| 9 Dec 2015 | Recall initiated by company | |
| 26 May 2016 | Classified by FDA | +169 days |
| 1 Jun 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac.
Product as listed by the FDA
Pink Bikini capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Lucy's Weight Loss System (dba Waisted With Lucy), Arlington, TX 76010
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac.
Which lots are affected?
All lots, all colors and all strengths
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 72820| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Shorts on the Beach capsules, (all colors and all strengths) recalled | Lucy's Weight Loss ( | Labeling Errors | Nationwide |
More recalls from Lucy's Weight Loss (
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Shorts on The Beach Golden Edition by Pink Bikini, 800 mg recalled | Lucy's Weight Loss ( | Labeling Errors | Nationwide |
| Drug | CLASS I | Shorts on the Beach capsules, (all colors and all strengths) recalled | Lucy's Weight Loss ( | Labeling Errors | Nationwide |
| Drug | CLASS I | Pink Bikini Strong Formula capsules, 750 mg recalled | Lucy's Weight Loss ( | Labeling Errors | Nationwide |
| Drug | CLASS I | Shorts on The Beach Strong Formula by Pink Bikini capsules, 750 mg recalled | Lucy's Weight Loss ( | Labeling Errors | Nationwide |