DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.

FDA Drug Recall #D-0573-2023 — Class I — April 26, 2023

Recall Summary

Recall Number D-0573-2023
Classification Class I — Serious risk
Date Initiated April 26, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Gadget Island, Inc
Location West Sacramento, CA
Product Type Drugs
Quantity 140 blister packs

Product Description

DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.

Reason for Recall

Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Distribution Pattern

Nationwide in the USA.

Lot / Code Information

Lot/Item#: OMS760-B, Exp: 12/2025

Other Recalls from Gadget Island, Inc

Recall # Classification Product Date
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-0106-2018 Class I grande X 5800 capsule, (Maca Root 120 mg, Horny... Sep 15, 2017
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.