Gold Hard Steel Plus Liquid recalled for undeclared acetaminophen and sildenafil
FDA has recalled Gold Hard Steel Plus Liquid because the product was marketed without FDA approval and contains undeclared pharmaceutical ingredients: acetaminophen and sildenafil.
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: FDA classified this as a Class I recall, the most serious category for drug recalls. The product was marketed without an approved NDA/ANDA and contained undeclared acetaminophen and sildenafil.
Plain-English summary
Gold Hard Steel Plus Liquid, sold in 2 FL OZ bottles (UPC 787188873199), is being recalled by Supercore Products Group Inc. The FDA classified this as a Class I recall, the most serious classification for drug recalls.
The product was marketed and sold without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). FDA analysis determined the product contained undeclared acetaminophen and sildenafil.
The recall affects approximately 615 units that were distributed nationwide in the United States, as well as Canada, the United Kingdom, Israel, Australia, Pakistan, Morocco, and the Republic of Kosovo. All lot codes are included in this recall.
Consumers who have purchased this product should stop using it immediately. Those who have already used this product should consult with a healthcare provider.
The recalled product
- Product
- Gold Hard Steel Plus Liquid, 2 FL OZ bottles, UPC 787188873199
- Manufacturer
- Supercore Products Group Inc.
- Affected units
- 615
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 2 recalled by Supercore Products Group Inc. 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 · Supercore Products Group Inc.
See all →- SevereHard Steel Capsules Recalled for Undeclared Acetaminophen and Sildenafil
FDA (Drugs) · 2024-10-09
Same hazard · undeclared acetaminophen
See all →- HighMultivitamin supplement recalled for undeclared drugs and aspartame
FDA (Food) · 2024-12-11
- HighHerbal Dietary Supplement Recalled for Undeclared Pharmaceuticals
FDA (Drugs) · 2024-10-02
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