Blue Fusion Capsules Recalled for Undeclared Prescription Ingredients
Ata International Inc is recalling Blue Fusion Capsules because FDA analysis found undeclared prescription ingredients, including Sildenafil and Tadalafil.
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
Ata International Inc is recalling Blue Fusion Capsules, 1-count blister packs, distributed by DNS Distribution. The product is identified by UPC 7 48252 66460 0. The recall covers all lots of the product.
The FDA is recalling this product because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). FDA analysis determined that the product contains undeclared ingredients, specifically Sildenafil, Tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin, and daidzein.
The product was distributed nationwide within the United States. Consumers should stop using the product and contact the distributor or manufacturer for further instructions.
The recalled product
- Product
- Blue Fusion Capsules, 1- count blister pack, Distributed by: DNS Distribution 5225 Canyon Crest Dr. Ste 71-640, Riverside, CA 92507, UPC 7 48252 66460 0
- Manufacturer
- Ata International Inc
- Category
- Drug — 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
Distribution
Distributed nationwide across the United States.
Related recalls
Same hazard · undeclared ingredients
See all →- CriticalFDA Recalls Addall XR Shot Liquid Dietary Supplement
FDA (Food) · 2026-09-02
- SevereD'Dioses Mango Ice Pops Recalled for Undeclared Allergens
FDA (Food) · 2026-07-22
- ModerateSuper ProTHIN Plus Dietary Supplement Recalled for Undeclared Dyes
FDA (Food) · 2025-07-02
- LowGaiser's Recalls Ready-to-Eat Bologna Due to Undeclared Meat Ingredients
USDA FSIS · 2025-06-27
- HighFlour tortillas recalled due to undeclared wheat allergen
FDA (Food) · 2024-05-29
Similar recalls
- CriticalBLUE Diamond Platinum Capsules Recalled for Undeclared Active Ingredients
FDA (Drugs) · 2013-05-22
- CriticalBlue Pearl Capsules Recalled for Undeclared Sildenafil
FDA (Drugs) · 2018-02-07
- SevereMAC DADDY PURPLE Capsules Recalled for Undeclared Drug Ingredients
FDA (Drugs) · 2022-02-23
- SevereMAC DADDY RED Capsules Recalled for Undeclared Drug Ingredients
FDA (Drugs) · 2022-02-23
- CriticalPremierZEN Platinum 8000 Capsules Recalled for Undeclared Drug Ingredients
FDA (Drugs) · 2021-06-30
- CriticalFDA Recalls Blue Diamond Pill for Undeclared Sildenafil and Tadalafil
FDA (Drugs) · 2013-05-22