FDA Recalls Black Gold X Advanced Capsules for Undeclared Sibutramine
The FDA is recalling Black Gold X Advanced capsules because they contain undeclared sibutramine and were marketed without an approved NDA/ANDA.
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 corresponds to a Critical severity score per the rubric.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Black Gold X Advanced capsules, 60-count bottles, manufactured for Making it A Lifestyle, L.L.C. The recall involves 1,000 bottles distributed nationwide. All lots are affected.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) and contains undeclared sibutramine. Sibutramine is a drug that was withdrawn from the U.S. market due to safety concerns.
Consumers who have purchased these products should stop using them and contact the manufacturer or the FDA for further instructions.
The recalled product
- Product
- BLACK GOLD X ADVANCED capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
- Manufacturer
- Making It a Lifestyle
- Category
- Drug — Dietary Supplement
- Affected units
- 1,000
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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Making It a Lifestyle under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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