FDA Recalls Unapproved X-Rock 3 Day Pill For Men
Coral Rock Man, Inc. is recalling X-Rock 3 Day Pill For Men because the product was marketed without an approved NDA/ANDA and tested positive for Sildenafil and analogs.
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
Coral Rock Man, Inc. is recalling X-Rock 3 Day Pill For Men, which is supplied in 1 and 2 capsule blister packs and 6, 12, and 24 count bottles. The product is distributed by MATE Enterprises in Miami, Florida, and some units are labeled as manufactured by CRM Laboratories and distributed by XRock Industries in Ft. Lauderdale, Florida. Other labels identify the product as X-Rock 3 Day Pill For Erectile Refunction, distributed by www.CoralXRock.Com in the Florida Keys, Florida.
The recall is being conducted because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Laboratory testing revealed that the product tested positive for Sildenafil and analogs of Sildenafil. The recall covers all lots and all codes.
The product was distributed to three distributors/wholesalers and then distributed nationwide by internet and retail sales. Consumers who have purchased this product should stop using it and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- X-ROCK 3 Day Pill For Men, supplied in 1 and 2 capsule blister packs and 6, 12 and 24 count bottles, UPC 0 00309 50792 7, Distributed by: MATE Enterprises, Miami, Florida 33139, Some labeled as: Manufactured by CRM Laboratories, Distributed by XRock Industries, Ft. Lauderdale…
- Manufacturer
- Coral Rock Man, Inc.
- Category
- Drug — Unapproved Supplement
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 All codes.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Coral Rock Man, 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 · Coral Rock Man, Inc.
See all →- CriticalZ-ROCK Male Supplement Recalled for Unapproved Sildenafil Content
FDA (Drugs) · 2012-11-07
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
- CriticalX-ROCK For Men Recalled for Unapproved Prescription Drug Ingredients
FDA (Drugs) · 2012-11-07
- CriticalFDA Recalls Unapproved ROCK-IT MAN Male Sexual Stimulant Capsules
FDA (Drugs) · 2013-05-22
- SevereFDA Recalls Unapproved MAX MAN Capsules Containing Sildenafil
FDA (Drugs) · 2018-02-07
- SevereMale Enhancement Capsules Recalled for Containing Unapproved Drug Ingredient
FDA (Drugs) · 2023-12-27
- CriticalVitility Recalls MAN OF STEEL Capsules Containing Undeclared Sildenafil
FDA (Drugs) · 2017-11-01
- SevereNUX Male Enhancement Capsules Recalled for Undeclared Prescription Ingredients
FDA (Drugs) · 2023-05-10