PapaZen 3300 capsules recalled for undeclared prescription ingredients
Gadget Island, Inc. is recalling PapaZen 3300 capsules because they contain undeclared prescription drugs sildenafil, desmethyl carbodenafil, and tadalafil.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which indicates a reasonable probability that use of or exposure to the violative product will cause serious adverse health consequences or death.
Plain-English summary
Gadget Island, Inc. is recalling PapaZen 3300 capsules, Proprietary Blend 1800mg, 1-capsule packets. The product was distributed nationwide in the USA by FX Power, San Diego, CA. The specific lot number is NSS050888 with an expiration date of 05-2018.
The recall was initiated because the product was marketed without an Approved NDA/ANDA and contains undeclared Active Pharmaceutical Ingredients: sildenafil, desmethyl carbodenafil, and tadalafil. These are prescription medications that were not listed on the product label.
Consumers who purchased this product should stop using it immediately. The presence of undeclared prescription ingredients poses a risk to consumers, particularly those with certain medical conditions or those taking other medications.
The recalled product
- Product
- PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distributed by FX Power San Diego, CA 92108, UPC 718122032587
- Manufacturer
- Gadget Island, Inc
- Category
- Drug — Dietary Supplement
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 (2)
- Lot# NSS050888
- EXP 05-2018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Gadget Island, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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