FDA Recalls Leopard Miracle Honey Containing Undeclared Sildenafil
USA LESS Inc. is recalling Leopard Miracle Honey because it contains undeclared sildenafil, an unapproved drug for erectile dysfunction.
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 according to the rubric.
Plain-English summary
USA LESS Inc. is recalling Leopard Miracle Honey packaged in a wooden box. The product contains 12 sachets and is manufactured in Turkey. The recall covers 83 boxes distributed nationwide in the USA.
The FDA is recalling this product because it is marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The honey is tainted with undeclared sildenafil, which is an FDA-approved drug used to treat male erectile dysfunction. The presence of sildenafil renders the product an unapproved drug for which safety and efficacy have not been established.
Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- LEOPARD Miracle Honey packaged in a wooden box, UPC 8 699415 910534, containing 12 sachets 180Gr / 6.36 Oz, each 1 Sachet 15 gr / 0.53 Oz is labeled as LEOPARD Miracle of Honey, UPC 8 699415 912859, Manufactured in Turkey, www leopardhoneytr.com.
- Manufacturer
- USA LESS Inc.
- Category
- Food — Honey
- Affected units
- 83
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.
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