FDA Drug recall D-1009-2019
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 offi…
- FDA Drug
- Class I
- terminated
- Published 2019-03-20
On 2019-03-20 the FDA classified a Class I recall of 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 offi… by Golean Detox Us, citing marketed Without an Approved NDA/ANDA: FDA analysis found product to contain undeclared sibutramine and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1009-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-02-22 |
| Published | 2019-03-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Golean Detox Us |
| Distribution | US |
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
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 Sibutramine is an appetite suppressant that was withdrawn from the US market due to safety concerns.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.
Identifiers
| upc | 8938510909013 |
|---|---|
| code_info | All lots remaining within expiry. |
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-1009-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.