Golean DETOX capsules — Class I drug recall D-1009-2019
Terminated recall by Golean Detox US, reported 2019-03-20, distributed nationwide. Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain undeclared sibutramine and phenol
| Recall number | D-1009-2019 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Golean Detox US, Charlotte, NC, United States |
| Recall initiated | 2019-02-22 |
| Classified | 2019-03-18 |
| Reported by FDA | 2019-03-20 |
| Terminated | 2021-01-26 |
| Distributed | Nationwide (US) |
| Quantity | 37 boxes |
| Reason classes | undeclared allergen, unapproved product |
Product
Golean DETOX capsules, 14 Net: 56 g, 14 packets containing 2 capsules per packet, 28-count capsules per box, MAT XI S.G Co., LTD, Head office: J29 Vo Thi Sau Street, Thong Nhat Ward, Bien Hoa City, Dong Nai Province, Viet Nam; Manufactory: 148/9 Tan Tien Ward, Bien Hoa City, Dong Nai Province, Viet Nam; Product distribution franshise by GoLean Detox Enterprise 002677155-A Malaysia, www.matxisg.com, UPC 8 938510 909013.
Reason for recall
Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain undeclared sibutramine and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the US market due to safety concerns. Phenolphthalein was once an ingredient used in over-the-counter laxatives, but because of concerns of carcinogenicity is not currently approved for marketing in the US. The presence of sibutramine and phenolphthalein in this product renders it an unapproved drug for which the safety and efficacy has not been established and, therefore, subject to recall.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1009-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.