Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported February 23, 2022
365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL
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NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market d…
Je Dois Lavoir LLC recalled 365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL - a critical-severity action.
365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL was recalled by Je Dois Lavoir LLC in February 23, 2022. Reason: Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutrami…. Check the official notice for the remedy. Verify recall #D-0631-2022 with the FDA Drug before acting.
The recall
Je Dois Lavoir LLC issued this critical-severity FDA Drug recall-Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutrami….
- Critical
- severity level
- Class I
- classification
- February 23, 2022
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0631-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0631-2022) was formally reported on February 23, 2022, with the manufacturer initiating the action on August 2, 2021. It is classified under Critical severity (Class I), with a current status of Terminated. Je Dois Lavoir LLC is listed as the recalling firm, operating out of Visalia, CA. Federal records list the affected scope as 783 bottles.
The documented reason for this recall is: 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NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns. Distribution data in the federal record shows the product reached: Sold online via website nationwide in the USA and Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
783 bottles
Related Recalls
6
5 from same agency
Product description
365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-0631-2022 |
| Date reported | February 23, 2022 |
| Date initiated | August 2, 2021 |
| Recalling firm | Je Dois Lavoir LLC |
| Firm location | Visalia, CA |
| Affected scope | 783 bottles |
| Distribution | Sold online via website nationwide in the USA and Canada. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0631-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL. Recalled by Je Dois Lavoir LLC. Units affected: 783 bottles.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Drug on February 23, 2022. Severity: Critical. Recall number: D-0631-2022.
Where was the recalled product distributed? ▼
Distribution: Sold online via website nationwide in the USA and Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0631-2022) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported February 23, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.