Blue Pearl capsules Recall: FDA Class I

Why it was recalled

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.

Product description

BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5

Lot numbers, UPCs & expiration codes

All lots

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0247-2018
Classification: Class I
Status: Terminated
Recall initiated: Nov 29, 2017
FDA report date: Feb 7, 2018
Quantity: 300 pill cards
Recall type: Voluntary: Firm initiated
Recalling firm: Blue Fusion Natural

Original FDA data

Every field from FDA enforcement report D-0247-2018, exactly as published.

Show all FDA fields

City: Orange
State: CA
Status: Terminated
Country: United States
Event ID: 78634
Address: 2942 E Chapman Ave # 132
Code information: All lots
Postal code: 92869-3745
Report date: Feb 7, 2018
Product type: Drugs
Recall number: D-0247-2018
Classification: Class I
Recalling firm: Blue Fusion Natural
Product quantity: 300 pill cards
Termination date: Dec 6, 2018
Reason for recall: 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.
Voluntary / mandated: Voluntary: Firm initiated
Product description: BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5
Distribution pattern: Nationwide
Recall initiation date: Nov 29, 2017
Initial firm notification: E-Mail
Center classification date: Feb 1, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0247-2018, published Feb 7, 2018. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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BLUE PEARL capsules Recall

Summary