The Recall Desk
CriticalFDA (Drugs)·D-0686-2021·Announced 2021-07-28

Thumbs Up 7 Black 25K Capsules Recalled for Undeclared Tadalafil

Nuri Trading LLC is recalling Thumbs Up 7 Black 25K capsules nationwide because they contain undeclared tadalafil, an FDA-approved drug. The product was marketed without required approval, making it an unapproved drug with unestablished safety and efficacy.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: This recall is classified as FDA Class I. Per the severity rubric, FDA Class I recalls are scored as Critical (5) regardless of other factors, as they represent the most serious safety hazard.

Plain-English summary

Nuri Trading LLC is recalling Thumbs Up 7 Black 25K capsules in all lots within expiry, distributed nationwide. The capsules are packaged in 1-count blister cards and 10-count boxes.

The product was found to be tainted with undeclared tadalafil, an FDA-approved drug. Because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), it is classified as an unapproved drug for which safety and efficacy have not been established.

Consumers who have purchased this product should stop using it and consult a healthcare provider with questions about their health or potential exposure.

The recalled product

Product
Thumbs Up 7 Black 25K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
Manufacturer
Nuri Trading LLC
Category
Drug — Unapproved Drug
Hazard
  • unapproved-drug
  • undeclared-tadalafil

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.

Related recalls

Same category