FDA Recalls Black Storm Capsules Marketed Without Approval
R Thomas Marketing, LLC is recalling Black Storm 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 text explicitly states the agency classification is 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 voluntarily recalling Black Storm, a product packaged in small boxes containing 6 capsules. The product was distributed nationwide via Internet sales. The recall covers all lots of the product.
The FDA is classifying this recall as Class I because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). This means the product has not been evaluated by the FDA for safety, efficacy, or quality.
Consumers who have purchased Black Storm should stop using the product and return it to the place of purchase for a refund. The product was sold online by R Thomas Marketing, LLC.
The recalled product
- Product
- Black Storm, packaged in SMALL BOX (6 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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