# FDA recall D-0106-2018

> **Gadget Island, Inc** · Class I · drug recall initiated 2017-09-15.

## 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

## Reason for recall

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

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0106-2018
- **Recalling firm:** Gadget Island, Inc
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-09-15
- **Report date:** 2017-12-13
- **Termination date:** 2018-12-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Newark, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0106-2018

## Citation

> AI Analytics. FDA recall D-0106-2018. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0106-2018. Source: US FDA. Licensed CC0.

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