Inaffit Recalls Natureal Burn Fat Nature Due to Undeclared Sibutramine
Inaffit, LLC is recalling Natureal Burn Fat Nature capsules because the product contains undeclared sibutramine and was marketed without an approved NDA or ANDA.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which per the rubric mandates a score of 5 (Critical) regardless of other factors, as it poses a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Inaffit, LLC is recalling 6,000 bottles of Natureal Burn Fat Nature, 30-count capsules, packaged in clear plastic bottles. The product was distributed nationwide. The recall affects all lots of the product.
The FDA identified that the product contains undeclared sibutramine. Additionally, the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Sibutramine is a drug that was withdrawn from the US market due to safety concerns, and its presence in a dietary supplement is a significant safety issue.
Consumers who have purchased Natureal Burn Fat Nature capsules should stop using the product immediately. They should contact Inaffit, LLC for further instructions on how to return the product or obtain a refund.
The recalled product
- Product
- NATUREAL BURN FAT NATURE, 30-count capsules, packaged in clear plastic bottle, Manufactured for: Inaffit, LLC. P.O. Box 34056, Bethesda, MD 20827.
- Manufacturer
- Inaffit, LLC
- Category
- Drug — Dietary Supplement
- Affected units
- 6,000
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.
Related recalls
Same hazard · undeclared drug
See all →- SevereSamurai-X Honey 6800 Recalled for Undeclared Drug Ingredients
FDA (Drugs) · 2024-05-01
- SevereFDA Recalls Flower Power Female Enhancement for Undeclared Sildenafil and Tadalafil
FDA (Drugs) · 2024-05-01
- SevereDietary supplement found to contain undeclared pharmaceutical drug tadalafil
FDA (Drugs) · 2022-07-27
- ModerateNOW Royal Jelly supplements may contain undeclared Metronidazole
FDA (Food) · 2021-11-17
- ModerateNOW Bee Pollen 500mg Capsules Recalled for Metronidazole Contamination
FDA (Food) · 2021-11-17