FDA Drug recall D-0631-2022
365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL
- FDA Drug
- Class I
- terminated
- Published 2022-02-23
On 2022-02-23 the FDA classified a Class I recall of 365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL by Je Dois Lavoir, citing 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NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market d….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0631-2022 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-08-02 |
| Published | 2022-02-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Je Dois Lavoir |
| Distribution | US |
Product
365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL
Reason
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NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.
Identifiers
| code_info | Lot 102-26, Exp Dec 2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0631-2022%22
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