The Recall Desk
SevereFDA (Drugs)·D-0688-2021·Announced 2021-07-28

69MODE Blue 69 Capsules Recalled for Undeclared Drug Ingredients

Nuri Trading LLC is recalling 69MODE Blue 69 capsules nationwide because they contain undeclared tadalafil and sildenafil, two FDA-approved drugs, making the product an unapproved drug without established safety or efficacy.

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 as a Class I recall. The product contains undeclared pharmaceutical active ingredients (tadalafil and sildenafil) in an unapproved drug formulation, presenting a serious safety hazard because the product lacks established safety and efficacy data.

Plain-English summary

Nuri Trading LLC is recalling 69MODE Blue 69 capsules, packaged in 10-count boxes, distributed nationwide in the United States.

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

Consumers who have purchased this product should stop using it immediately. Anyone with questions or concerns should contact the recalling firm, Nuri Trading LLC.

The recalled product

Product
69MODE Blue 69 capsule, packaged in 10-count box, Nuri Trading LLC
Manufacturer
Nuri Trading LLC
Category
Drug — Unapproved Drug
Hazard
  • undeclared-active-ingredients
  • unapproved-drug
  • tadalafil
  • sildenafil

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