Hard Steel Capsules Recalled for Undeclared Acetaminophen and Sildenafil
Hard Steel Capsules contain undeclared acetaminophen and sildenafil and were marketed without FDA approval. All 729 units distributed nationwide and internationally are included in the recall.
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 Class I classification requires a minimum severity score of 4. Although no illnesses or injuries have been reported, the undeclared presence of pharmaceutical ingredients in an unapproved product represents a serious health risk.
Plain-English summary
Supercore Products Group Inc. is recalling Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20, and 30 units. FDA analysis found these capsules contain undeclared acetaminophen and sildenafil, pharmaceutical ingredients not listed on the product packaging.
The products were marketed without FDA approval. Hard Steel Capsules are not authorized to contain acetaminophen and sildenafil without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
A total of 729 units have been distributed, including nationwide distribution in the United States and distribution to Canada, Israel, Australia, United Kingdom, Pakistan, Morocco, and the Republic of Kosovo. All lots are included in this recall.
Consumers who have purchased these products should discontinue use immediately. Anyone who has consumed these capsules and has health concerns should contact their healthcare provider.
The recalled product
- Product
- Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.
- Manufacturer
- Supercore Products Group Inc.
- Category
- Drug
- Affected units
- 729
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 →- SevereGold Hard Steel Plus Liquid 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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