CLASS I Drug recall · Reported 23 Feb 2022 · FDA Enforcement Report
600 mg, Body Balance Internacional recalled by Je Dois Lavoir
Je Dois Lavoir is recalling 600 mg, Body Balance Internacional, distributed nationwide in the US. The recall was initiated on 2 Aug 2021 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-0631-2022
- FDA event ID
- 88409
- Recalling firm
- Je Dois Lavoir, Visalia, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 2 Aug 2021
- FDA classified
- 23 Feb 2022
- Reported
- 23 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
Timeline
| 2 Aug 2021 | Recall initiated by company | |
| 23 Feb 2022 | Classified by FDA | +205 days |
| 23 Feb 2022 | Published in enforcement report | +0 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NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.
Product as listed by the FDA
365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL
Where it was distributed
Sold online via website nationwide in the USA and Canada.
Stores named: Online Retailers
Questions about this recall
Why was it recalled?
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.
Which lots are affected?
Lot 102-26, Exp Dec 2022
Where was it sold?
Sold online via website nationwide in the USA and Canada.
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.