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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Dietary Supplements

Blue Fusion Natural: Blue Pearl Capsules Recalled for Undeclared Sildenafil

Agency Publication Date: February 1, 2018
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Summary

Blue Fusion Natural is recalling approximately 300 units of Blue Pearl capsules (500mg) because they were found to contain sildenafil, an undeclared active ingredient. Sildenafil is an FDA-approved drug used to treat erectile dysfunction, but its presence in these capsules makes them an unapproved drug with unestablished safety and efficacy. These products were distributed nationwide in 1-count packets (pill cards) through Blue Pearl in Long Beach, California. Consumers should immediately stop using these capsules and contact a healthcare provider, as this undeclared ingredient can cause serious health risks.

Risk

The undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous or life-threatening levels. This pose a significant risk to individuals with diabetes, high blood pressure, high cholesterol, or heart disease who often take nitrates.

What You Should Do

  1. Check your supplements for BLUE PEARL capsules (500mg) sold in 1-count packets (pill cards) with UPC 8 4704600978 5.
  2. Verify if you have any packets from 'All lots', as the entire product line is affected by this recall.
  3. Immediately stop using any remaining Blue Pearl capsules and dispose of them or return them to the place of purchase.
  4. Contact your healthcare provider or pharmacist for guidance if you have consumed this product, especially if you take prescription medications containing nitrates.
  5. Return any unused product to the place of purchase for a refund and contact Blue Fusion Natural for further instructions regarding this recall.
  6. For additional questions or to report a reaction, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: BLUE PEARL capsules (500mg)
Model:
D-0247-2018
UPC Codes:
847046009785
Lot Numbers:
All lots

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78634
Status: Resolved
Manufacturer: Blue Fusion Natural
Sold By: Blue Pearl Long Beach, CA
Manufactured In: United States
Units Affected: 300 pill cards
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.