Male Enhancement Capsules Recalled for Containing Unapproved Drug Ingredient
THE ROCK male enhancement capsules are recalled because they contain Sildenafil, a pharmaceutical ingredient not approved for this product. The product was distributed in Florida, the Bahamas, and Turks & Caicos Islands.
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 recall of an unapproved drug product containing an undisclosed pharmaceutical ingredient. Although no illnesses have been reported, the regulatory violation and inherent risk of adverse health consequences from consuming an unauthorized drug justify the Class I classification.
Plain-English summary
THE ROCK Male Sexual Performance Enhancement Capsules (1200 mg, 1-count blister cards) distributed by Steele Productions in Hallandale, Florida are being recalled by the FDA.
FDA analysis found that the product contains Sildenafil, an ingredient found in FDA-approved medications for male sexual enhancement. The product was marketed and sold without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), making it an illegal unapproved drug.
The product was distributed in Florida, the Bahamas, and the Turks & Caicos Islands. Consumers who have purchased this product should not consume it and should dispose of it properly. Those with concerns about consumption should contact their healthcare provider.
The recalled product
- Product
- THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card, Distributed by Steele Productions: Hallandale, FL 33008 UPC 6 61799 95052 7
- Manufacturer
- Noah's Wholesale LLC
- Category
- Drug
- Affected units
- 173
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)
- Lot# 03032021 Exp: 12/31/2027
Distribution
Distributed in 1 state:
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