The Recall Desk
CriticalFDA (Drugs)·D-1117-2017·Announced 2017-08-30

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.

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 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
Hazard

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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