FDA Recalls Unapproved ROCK-IT MAN Male Sexual Stimulant Capsules
Consumer Concepts is recalling ROCK-IT MAN capsules because FDA analysis found they contain an unapproved sildenafil analogue.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Consumer Concepts, Inc. is recalling ROCK-IT MAN capsules, a male sexual stimulant, because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). FDA analysis determined that the product contains hydroxythiohomosildenafil, an analogue of sildenafil, which is an ingredient in an FDA-approved drug for the treatment of male erectile dysfunction. This finding classifies the product as an unapproved new drug.
The recall involves 11,424 blister packs of ROCK-IT MAN capsules, distributed nationwide. The product was packaged in 1-count blister cards (UPC 8 53447 02003 8) and 2-count blister cards (UPC 8 53447 00204 1). All product sold between January 1, 2013, and March 27, 2013, is affected.
Consumers who have purchased this product should stop using it and contact Consumer Concepts, Inc. for further instructions or a refund.
The recalled product
- Product
- ROCK-IT MAN capsules, male sexual stimulant, packaged in 1-count (UPC 8 53447 02003 8) and 2-count (UPC 8 53447 00204 1) blister cards, Distributed by Consumer Concepts.
- Manufacturer
- Consumer Concepts, Inc.
- Category
- Drug — Unapproved New Drug
- Affected units
- 11,424
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 product sold between 01/01/13 through 03/27/13.
Distribution
Distributed nationwide across the United States.
Related recalls
Same hazard · unapproved drug
See all →- CriticalBuy-Herbal Recalls Kian Pee Wan Capsules for Undeclared Drug Ingredients
FDA (Drugs) · 2026-08-19
- SevereMR. 7 Super capsules recalled as Class I over undeclared sildenafil
FDA (Drugs) · 2026-03-11
- SevereMojo Max Fusion capsules recalled as Class I over undeclared drug ingredients
FDA (Drugs) · 2026-03-11
- SevereSilintan herbal pills recalled as Class I for undeclared meloxicam
FDA (Drugs) · 2026-03-11
- SevereAgebox iKids-Growth Day Formula Capsules Recalled Over Undeclared Drug Ingredient
FDA (Drugs) · 2026-03-04
Similar recalls
- CriticalFDA Recalls Unapproved X-Rock 3 Day Pill For Men
FDA (Drugs) · 2012-11-07
- SevereMale Enhancement Capsules Recalled for Containing Unapproved Drug Ingredient
FDA (Drugs) · 2023-12-27
- CriticalZ-ROCK Male Supplement Recalled for Unapproved Sildenafil Content
FDA (Drugs) · 2012-11-07
- CriticalVitility Recalls MAN OF STEEL Capsules Containing Undeclared Sildenafil
FDA (Drugs) · 2017-11-01
- SevereFDA Recalls Unapproved MAX MAN Capsules Containing Sildenafil
FDA (Drugs) · 2018-02-07
- CriticalX-ROCK For Men Recalled for Unapproved Prescription Drug Ingredients
FDA (Drugs) · 2012-11-07