Hardcore Formulations Recalls D-ZINE Rapid Size and Strength Capsules
Hardcore Formulations is recalling D-ZINE Rapid Size and Strength capsules because they contain unapproved active ingredients.
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 severity score of at least 4 according to the rubric.
Plain-English summary
Hardcore Formulations is recalling 1,440 bottles of D-ZINE Rapid Size and Strength capsules, 10mgs, 90 count bottle. The product was distributed nationwide.
The FDA determined that the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The capsules contain Methylstenbolone or Dymethazine, which are not approved for use in this product.
Consumers who have purchased this product should stop using it and contact the manufacturer for a refund or further instructions.
The recalled product
- Product
- D-ZINE Rapid Size and Strength capsules, 10mgs, 90 count bottle, Hardcore Formulations, UPC: 7 48252 86193 1
- Manufacturer
- HARDCORE FORMULATIONS
- Category
- Drug — Supplement
- Hazard
- Affected units
- 1,440
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 →- SevereFDA Recalls Ultra-Sten Capsules Marketed Without Approval
FDA (Drugs) · 2017-08-23
Same hazard · unapproved ingredient
See all →- Severe
- HighAlpha Test supplement capsules recalled for unapproved cathine ingredient
FDA (Food) · 2025-02-05
- HighTruvy Boost Dietary Supplement Kit Recalled for Unapproved Ingredients
FDA (Food) · 2023-05-31
- ModerateDietary supplement Tight! Xtreme Reloaded recalled for unapproved ingredient
FDA (Food) · 2021-06-30
- SevereFDA Recalls PremierZen Black 5000 for Unapproved Tadalafil
FDA (Drugs) · 2021-05-26
Similar recalls
- CriticalBiotech Underground Tri-Ton Hardcore Formula Recalled for Unapproved Ingredients
FDA (Drugs) · 2017-08-23
- CriticalMira Health Recalls Super-DMZ Rx 2.0 Capsules for Unapproved Steroid Ingredient
FDA (Drugs) · 2014-03-12
- SevereHard Steel Capsules Recalled for Undeclared Acetaminophen and Sildenafil
FDA (Drugs) · 2024-10-09
- CriticalFDA Recalls Hard Ten Days Capsules for Unapproved Sildenafil
FDA (Drugs) · 2012-10-03
- SevereFDA Recalls Unapproved Libigrow XXXTREME Capsules Containing Undeclared Ingredients
FDA (Drugs) · 2013-05-22
- SevereUnapproved Drug Capsule Recalled for Undeclared Sexual Enhancement Ingredients
FDA (Drugs) · 2023-05-10