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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
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.
Part of a larger recall action
This product is one of 4 recalled by Nuri Trading LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Nuri Trading LLC
See all →- SevereThumbs Up 7 White Capsules Recalled for Undeclared Pharmaceutical Ingredients
FDA (Drugs) · 2021-07-28
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FDA (Drugs) · 2021-07-28
- CriticalShogun-X 7000 Capsules Recalled for Undeclared Prescription Drug Ingredients
FDA (Drugs) · 2021-07-28
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