FDA Recalls Ultra-Sten Capsules Marketed Without Approval
Hardcore Formulations is recalling Ultra-Sten capsules because they contain unapproved ingredients and were marketed without an approved NDA or 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 agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Ultra-Sten Rapid Size and Strength capsules, 10 mgs, 90 count bottles, manufactured by Hardcore Formulations. The product is identified by UPC 7 48252 68763 0.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The FDA determined that the product contains Methylstenbolone or Dymethazine, which are not approved for use in this context.
Approximately 1,490 bottles were distributed nationwide. All lots remaining within their expiration dates are affected. Consumers should stop using the product and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- ULTRA-STEN Rapid Size and Strength capsules, 10 mgs, 90 count bottle, Hardcore Formulations UPC: 7 48252 68763 0
- Manufacturer
- HARDCORE FORMULATIONS
- Category
- Drug — Unapproved Supplement
- Affected units
- 1,490
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 remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by HARDCORE FORMULATIONS 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 2 products in this recall →Related recalls
Same manufacturer · HARDCORE FORMULATIONS
See all →- SevereHardcore Formulations Recalls D-ZINE Rapid Size and Strength Capsules
FDA (Drugs) · 2017-08-23
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