Happy Passengers Recalled for Lack of FDA Approval
R Thomas Marketing, LLC is recalling Happy Passengers capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
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 source metadata explicitly identifies the agency classification as Class I. According to the rubric, if the agency's own classification is FDA Class I, the score must never go below 4.
Plain-English summary
R Thomas Marketing, LLC is recalling Happy Passengers, a product packaged in a BIG BOX containing 30 small boxes with one capsule per box. The product was distributed nationwide via Internet sales by R Thomas Marketing, LLC, located in Bronx, NY 10467. All lots are affected by this recall.
The recall is being conducted because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). This indicates the product has not undergone the FDA's review process to ensure its safety, efficacy, and quality.
Consumers who have purchased Happy Passengers should stop using the product and contact R Thomas Marketing, LLC for further instructions or a refund. The FDA classifies this recall as Class I, which is the most serious type of recall.
The recalled product
- Product
- Happy Passengers, packaged in BIG BOX (30 small boxes / 1 capsule per box / 30 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
- Manufacturer
- R Thomas Marketing, LLC
- Category
- Drug — Unapproved Drug
- Hazard
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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 recalled by R Thomas Marketing, 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.
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