Golean DETOX capsules recalled for undeclared sibutramine and phenolphthalein
Golean Detox US is recalling Golean DETOX capsules because FDA analysis found undeclared sibutramine and phenolphthalein, ingredients not approved for marketing in the US.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 per the rubric.
Plain-English summary
Golean Detox US is recalling 37 boxes of Golean DETOX capsules, 28-count capsules per box. The product was distributed nationwide in the USA. The recall covers all lots remaining within expiry.
The FDA is recalling this product because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). FDA analysis found the product contains undeclared sibutramine and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the US market due to safety concerns. Phenolphthalein was once used in over-the-counter laxatives but is not currently approved for marketing in the US due to concerns of carcinogenicity.
The presence of these undeclared ingredients renders the product an unapproved drug for which safety and efficacy have not been established. Consumers should stop using the product and contact the recalling firm for instructions on how to return it.
The recalled 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…
- Manufacturer
- Golean Detox US
- Category
- Drug — Dietary Supplement
- Affected units
- 37
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots remaining within expiry.
Distribution
Distributed nationwide across the United States.
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