The Recall Desk
SevereFDA (Drugs)·D-0687-2021·Announced 2021-07-28

Thumbs Up 7 White Capsules Recalled for Undeclared Pharmaceutical Ingredients

Nuri Trading LLC is recalling Thumbs Up 7 White 11K capsules nationwide because they contain undeclared prescription drug ingredients (tadalafil, sildenafil, and vardenafil) and lack FDA approval.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class I. According to the severity rubric, FDA Class I recalls with no reported illnesses must score at least 4 (Severe), since the agency's own classification overrides lower scores.

Plain-English summary

Nuri Trading LLC is recalling Thumbs Up 7 White 11K capsules in all lots within expiry, distributed nationwide in the United States. The capsules are packaged in either 1-count blister cards or 10-count boxes.

The product was found to be tainted with undeclared tadalafil, sildenafil, and vardenafil—all FDA-approved drugs for specific medical conditions. Because these drugs are present but undeclared, and the product itself lacks an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), the product is an unapproved drug.

Unapproved drugs pose a safety concern because their safety and efficacy have not been established. Consumers who have purchased this product should stop using it and consult a healthcare provider if they have questions about their health or the ingredients they may have ingested.

The recalled product

Product
Thumbs Up 7 White 11K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
Manufacturer
Nuri Trading LLC
Hazard
  • undeclared-pharmaceutical-ingredients
  • unapproved-drug
  • tadalafil
  • sildenafil
  • vardenafil

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • all lots within expiry

Distribution

Distributed nationwide across the United States.