CaverFlo Natural Herbal Coffee Recalled for Undeclared Sildenafil and Tadalafil
The FDA is recalling CaverFlo Natural Herbal Coffee because it contains undeclared sildenafil, tadalafil, and milk. The product was marketed without an approved NDA or 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 mandates a severity score of 5 according to the rubric.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling CaverFlo Natural Herbal Coffee, 25 g, supplied in boxes of 10 packets. The product is manufactured for Caverflo Texas Trading and distributed in Texas. The recall is due to the product being marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
FDA analysis revealed that the product contains sildenafil and tadalafil, which are prescription drugs, as well as undeclared milk. The presence of undeclared milk poses a risk to consumers with milk allergies. The recall covers all lots within the expiration date.
Consumers who have purchased this product should stop using it and contact the recalling firm, Brian P. Richardson, for further instructions. The product is identified by UPC 9555671709987.
The recalled product
- Product
- CaverFlo Natural Herbal Coffee, 25 g, supplied in boxes of 10 packets, manufacture for Caverflo Texas Trading -- UPC: 9555671709987
- Manufacturer
- Brian P. Richardson
- Category
- Drug — Herbal Supplement
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 within expiry.
Distribution
Distributed in 1 state:
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