Blue Fusion Natural recalls BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5
FDA recalls Blue Pearl 500mg capsules due to undeclared sildenafil, an unapproved drug with unknown safety. All units distributed by Blue Fusion Natural are affected.
Recall notice
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
Contact the company & request your remedy
What happened, in plain English
Blue Fusion Natural is recalling all 500mg BLUE PEARL capsules because they contain sildenafil without FDA approval. This makes the product unsafe as its safety and effectiveness haven't been tested. Read more at govinfonow.com/recall/41040-blue-pearl-500mg-capsules-recalled-unapproved-sildenafil-content.
Source Summary by GovInfoNow · govinfonow.com/recall/41040-blue-pearl-500mg-capsules-recalled-unapproved-sildenafil-content · Updated October 7, 2026 · FDA enforcement record: FDA #D-0247-2018
Cite this page
“Blue Pearl 500mg Capsules Recalled: Unapproved Sildenafil Content.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41040-blue-pearl-500mg-capsules-recalled-unapproved-sildenafil-content. Based on FDA recall #D-0247-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0247-2018%22&limit=1).
Why it’s dangerous
The capsules contain sildenafil, a drug approved for erectile dysfunction but not approved for use in this product. Since it's unapproved, the FDA hasn't tested its safety or effectiveness, which could cause health risks.
Who’s affected
Anyone who purchased Blue Pearl 500mg capsules from Blue Fusion Natural. People using these capsules for erectile dysfunction or other purposes are at risk due to unapproved ingredients.
How to tell if you have this one
Check for BLUE PEARL capsules labeled 500mg, 1-count packets with UPC 8 4704600978 5. All lots distributed by Blue Fusion Natural in California are affected.
- Brand
Blue Fusion Natural- Product
BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5- Category
Drug
What to do — step by step
Check Product Details
Look for the product name, dosage, and UPC code to confirm if it matches the recalled items.
Questions people ask
Why is this product being recalled?
The FDA found undeclared sildenafil in the product, which is an unapproved drug with unknown safety and effectiveness.
Is this product safe to use?
No, the product contains sildenafil without FDA approval, so it has not been tested for safety and could cause health risks.
How can I tell if I have the recalled product?
Check for BLUE PEARL capsules labeled 500mg, 1-count packets with UPC 8 4704600978 5 distributed by Blue Fusion Natural.
Contact Blue Fusion Natural
We’ve drafted a message you can send Blue Fusion Natural to request your refund or repair — edit it as you like.
Subject: Recall D-0247-2018 — Blue Fusion Natural BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Bea Hello, I own a BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5 that is covered by recall D-0247-2018 from Blue Fusion Natural. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0247-2018 (November 29, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0247-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.