Blue Pearl Capsules Recalled for Undeclared Sildenafil
Blue Fusion Natural is recalling Blue Pearl capsules because FDA analysis found undeclared sildenafil, an unapproved drug for erectile dysfunction.
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
Blue Fusion Natural is recalling Blue Pearl capsules, 500mg, 1-count packets, distributed by Blue Pearl in Long Beach, CA. The product is identified by UPC 8 4704600978 5. The recall covers 300 pill cards and all lots.
The FDA determined that the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). FDA analysis found that the capsules contain undeclared sildenafil, which is an FDA-approved drug for the treatment of erectile dysfunction. Because the product contains this undeclared active ingredient, it is considered an unapproved drug for which safety and efficacy have not been established.
The recall is classified as Class I by the FDA. The distribution pattern is listed as nationwide. Consumers who have purchased this product should stop using it and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5
- Manufacturer
- Blue Fusion Natural
- Category
- Drug — Unapproved Drug
- Affected units
- 300
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 ingredient
See all →- ModerateWise Onion Rings recalled for undeclared food color additives
FDA (Food) · 2026-07-15
- ModerateDietary supplement Ocular Plus recalled for undeclared Yellow #5
FDA (Food) · 2026-07-08
- ModerateDietary Supplement Vista MAX Recalled for Undeclared Yellow #5 Allergen
FDA (Food) · 2026-07-08
- ModerateEl David Gelee Bonbons Recalled for Undeclared Color Additives
FDA (Food) · 2026-07-01
- HighAdndale magnesium glycinate gummies contain undeclared melatonin in three lots
FDA (Food) · 2026-06-24