Shogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC

FDA Drug Recall #D-0685-2021 — Class I — March 29, 2021

Recall Summary

Recall Number D-0685-2021
Classification Class I — Serious risk
Date Initiated March 29, 2021
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Nuri Trading LLC
Location Fort Lee, NJ
Product Type Drugs
Quantity N/A

Product Description

Shogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC

Reason for Recall

Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.

Distribution Pattern

USA Nationwide

Lot / Code Information

all lots within expiry

Other Recalls from Nuri Trading LLC

Recall # Classification Product Date
D-0687-2021 Class I Thumbs Up 7 White 11K capsule, packaged in a) 1... Mar 29, 2021
D-0686-2021 Class I Thumbs Up 7 Black 25K capsule, packaged in a) 1... Mar 29, 2021
D-0688-2021 Class I 69MODE Blue 69 capsule, packaged in 10-count bo... Mar 29, 2021

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.