Hard Ten Days capsules recalled for lack of FDA approval
R Thomas Marketing, LLC is recalling Hard Ten Days capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
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: The agency classification is FDA Class I, which per the rubric mandates a score of 5 (Critical) regardless of other factors.
Plain-English summary
R Thomas Marketing, LLC is recalling Hard Ten Days, a product packaged in a BIG BOX containing 6 small boxes with 6 capsules each (36 capsules total). The product was distributed nationwide via Internet sales.
The recall is being conducted because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). This means the drug has not been evaluated by the FDA for safety, efficacy, or quality.
Consumers who have purchased this product should stop using it and contact the distributor for further instructions. The recall applies to all lots of the product.
The recalled product
- Product
- Hard Ten Days, packaged in BIG BOX (6 small boxes / 6 capsules per box / 36 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.
See all 24 products in this recall →Related recalls
Same manufacturer · R Thomas Marketing, LLC
See all →- SevereMan King capsules recalled for lack of FDA approval
FDA (Drugs) · 2016-06-01
- SevereFDA Recalls Black Storm Capsules Marketed Without Approval
FDA (Drugs) · 2016-06-01
- SevereFDA Recalls Zhen Gong Fu for Lack of Approved New Drug Application
FDA (Drugs) · 2016-06-01
- SevereBull's Genital Recalled for Marketing Without FDA Approval
FDA (Drugs) · 2016-06-01
- SeverePlant Vigra Recalled for Lack of FDA Approval
FDA (Drugs) · 2016-06-01
Same hazard · unapproved drug
See all →- CriticalBuy-Herbal Recalls Kian Pee Wan Capsules for Undeclared Drug Ingredients
FDA (Drugs) · 2026-08-19
- SevereMR. 7 Super capsules recalled as Class I over undeclared sildenafil
FDA (Drugs) · 2026-03-11
- SevereMojo Max Fusion capsules recalled as Class I over undeclared drug ingredients
FDA (Drugs) · 2026-03-11
- SevereSilintan herbal pills recalled as Class I for undeclared meloxicam
FDA (Drugs) · 2026-03-11
- SevereAgebox iKids-Growth Day Formula Capsules Recalled Over Undeclared Drug Ingredient
FDA (Drugs) · 2026-03-04