grande X 5800 capsule, (Maca Root 120 mg, Horny Goat Weed 120 mg, Guarana Seed 80 mg, Ginko Leaf ...
FDA Drug Recall #D-0106-2018 — Class I — September 15, 2017
Recall Summary
| Recall Number | D-0106-2018 |
| Classification | Class I — Serious risk |
| Date Initiated | September 15, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Gadget Island, Inc |
| Location | Newark, CA |
| Product Type | Drugs |
| Quantity | 198 1-capsule packets |
Product Description
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 Pattern
Nationwide in the USA
Lot / Code Information
All Lots
Other Recalls from Gadget Island, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0573-2023 | Class I | DYNAMITE SUPER capsule, 58,000 MG, 1-count blis... | Apr 26, 2023 |
| D-0571-2023 | Class I | Pro Power Knight Plus capsule, 2550mg, 1-count ... | Apr 26, 2023 |
| D-0572-2023 | Class I | NUX Male Enhancement capsule, 1-count blister c... | Apr 26, 2023 |
| D-0105-2018 | Class I | FIFTY SHADES 6000 capsule, Proprietary Raw Mate... | Sep 15, 2017 |
| D-0104-2018 | Class I | PapaZen 3300 capsule, Proprietary Blend 1800mg,... | Sep 15, 2017 |
Frequently Asked Questions
Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.