FDA Recalls Natural Herbal Coffee AMPT for Undeclared Sildenafil and Tadalafil
The FDA is recalling Natural Herbal Coffee AMPT 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 score of 5 per the rubric. The source also explicitly mentions that the undeclared milk allergen has caused deaths due to anaphylactic shock.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Natural Herbal Coffee AMPT, manufactured for The Ampt Life, LLC. The product is sold in 25g packages (UPC 6942630905) and 10-count boxes (UPC 6942630912). The recall covers 1,380 packets distributed nationwide in the USA.
FDA analysis found that the product contains undeclared sildenafil and tadalafil, as well as undeclared milk. The presence of sildenafil and tadalafil makes the product an unapproved drug for which safety and efficacy have not been established. Additionally, the product contains undeclared milk, which is a recognized allergen that has caused deaths due to anaphylactic shock in persons with underlying hypersensitivities.
Consumers should stop using this product and return it to the place of purchase or contact the recalling firm for instructions.
The recalled product
- Product
- NATURAL HERBAL COFFEE AMPT, sold in 25g packages (UPC 6942630905), 10-count packages per box (UPC 6942630912); Manufactured For: The Ampt Life, LLC.
- Manufacturer
- The Ampt Life, LLC
- Category
- Drug — Unapproved Drug
- Affected units
- 1,380
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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