FDA Recalls New Kopi Jantan Coffee for Undeclared Ingredients
Bestherbs Coffee LLC is recalling New Kopi Jantan coffee packets because they contain undeclared desmethyl carbodenafil and milk.
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 meets the rubric criteria for a Critical severity score.
Plain-English summary
Bestherbs Coffee LLC is recalling 6,250 packets of New Kopi Jantan Tradisional Natural Herbs Coffee. The product is packaged in 13-gram red packets, with 25 packets per box, and was manufactured in Malaysia. The specific lot has a UPC of 557205060083 and an expiration date of 5/24/18.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the product contains undeclared desmethyl carbodenafil and undeclared milk. The presence of undeclared milk poses a risk to consumers with milk allergies, while the undeclared drug ingredient poses risks to consumers with certain medical conditions or those taking specific medications.
The recalling firm distributed the product to two consignees in Texas. However, the firm reported that the product was subsequently distributed nationwide to consumers via individuals or the internet. Consumers who have this product should stop using it and contact the distributor for further instructions.
The recalled product
- Product
- New Kopi Jantan Tradisional Natural Herbs Coffee, packaged in 13 gram red packets, and each box contains 25 packets, Made in Malaysia, USA Distributor: Bestherbscoffee LLC (USA), Email: [email protected]
- Manufacturer
- BESTHERBS COFFEE LLC
- Category
- Food — Coffee / Herbal Beverage
- Affected units
- 6,250
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 (2)
- UPC 557205060083
- Exp 5/24/18
Distribution
Related recalls
Same hazard · undeclared drug
See all →- SevereFDA Recalls X10 Supplement Containing Undeclared Sildenafil and Tadalafil
FDA (Food) · 2026-10-14
- SeverebiQ-FEL Beverage Recalled for Undeclared Sildenafil and Tadalafil
FDA (Food) · 2026-10-14
- SevereFDA Recalls Flower Power Female Enhancement for Undeclared Sildenafil and Tadalafil
FDA (Drugs) · 2024-05-01
- SevereSamurai-X Honey 6800 Recalled for Undeclared Drug Ingredients
FDA (Drugs) · 2024-05-01
- SevereDietary supplement found to contain undeclared pharmaceutical drug tadalafil
FDA (Drugs) · 2022-07-27
Similar recalls
- CriticalHerbal Coffee Recalled for Undeclared Erectile Dysfunction Drugs
FDA (Drugs) · 2019-04-24
- CriticalFDA Recalls Natural Herbal Coffee AMPT for Undeclared Sildenafil and Tadalafil
FDA (Drugs) · 2017-12-27
- CriticalCaverFlo Natural Herbal Coffee Recalled for Undeclared Sildenafil and Tadalafil
FDA (Drugs) · 2017-08-30
- HighCoffee Product Recalled for Undeclared Soy and Coconut Allergens
FDA (Food) · 2024-05-08
- HighGreen Tea Latte Recalled for Undeclared Allergens
FDA (Food) · 2018-07-18
- SeverePure Herbs Protein Extract Recalled for Undeclared Milk and Soy Allergens
FDA (Food) · 2013-06-19