Gadget Island PapaZen capsule Recall: FDA Class I

Why it was recalled

Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.

Product description

PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distributed by FX Power San Diego, CA 92108, UPC 718122032587

Lot numbers, UPCs & expiration codes

Lot# NSS050888, EXP 05-2018

Where it was sold

Nationwide in the USA

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-0104-2018
Classification: Class I
Status: Terminated
Recall initiated: Sep 15, 2017
FDA report date: Dec 13, 2017
Quantity: 89 1-capsule packets
Recall type: Voluntary: Firm initiated
Recalling firm: Gadget Island, Inc

Original FDA data

Every field from FDA enforcement report D-0104-2018, exactly as published.

Show all FDA fields

City: Newark
State: CA
Status: Terminated
Country: United States
Event ID: 78151
Address: 5889 Central Ave
Code information: Lot# NSS050888, EXP 05-2018
Postal code: 94560-4465
Report date: Dec 13, 2017
Product type: Drugs
Recall number: D-0104-2018
Classification: Class I
Recalling firm: Gadget Island, Inc
Product quantity: 89 1-capsule packets
Termination date: Dec 4, 2018
Reason for recall: Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Voluntary / mandated: Voluntary: Firm initiated
Product description: PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distributed by FX Power San Diego, CA 92108, UPC 718122032587
Distribution pattern: Nationwide in the USA
Recall initiation date: Sep 15, 2017
Initial firm notification: E-Mail
Center classification date: Dec 4, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0104-2018, published Dec 13, 2017. View the source record (openFDA) · FDA enforcement reports

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

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

Gadget Island PapaZen 3300 capsule Recall

Summary