Grande X 5800 Capsule (Gadget Island) – Undeclared Ingredients (2017)
Class I: 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
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
grande X 5800 capsule, (Maca Root 120 mg, Horny Goat Weed 120 mg, Guarana Seed 80 mg, Ginko Leaf 60 mg, Saw Palmetto 100 mg, Damiana Leaf 100 mg, Ginseng Root 80 mg, Tribulus Terrestris 90 mg, Tongkat Alo 100 mg, Rhodiola Rosea 60 mg, L-Arginine 90 mg), 1-capsule packets, distributed by Grande X Ontario, CA 91745, UPC 640793555440
Brand
Gadget Island, Inc
Lot Codes / Batch Numbers
All Lots
Products Sold
All Lots
Gadget Island, Inc is recalling grande X 5800 capsule, (Maca Root 120 mg, Horny Goat Weed 120 mg, Guarana Seed 80 mg, Ginko Leaf 60 due to Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026