CLASS I Drug recall · Reported 7 Nov 2012 · FDA Enforcement Report
X-rock 3 Day Pill For Men, supplied in 1 and blister packs recalled
Coral Rock Man is recalling X-rock 3 Day Pill For Men, supplied in 1 and blister packs and 6, 12, distributed nationwide in the US. The recall was initiated on 16 Jul 2012 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-038-2013
- FDA event ID
- 62543
- Recalling firm
- Coral Rock Man, Key Colony Beach, FL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 16 Jul 2012
- FDA classified
- 1 Nov 2012
- Reported
- 7 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Hidden Drug Ingredients
Timeline
| 16 Jul 2012 | Recall initiated by company | |
| 1 Nov 2012 | Classified by FDA | +108 days |
| 7 Nov 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.
Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.
Product as listed by the FDA
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, FL, Also, labeled as X-Rock 3 Day Pill For Erectile Refunction, Distributed by www. CoralXRock.Com, Florida Keys, Florida
Where it was distributed
Product was distributed to three distributors/wholesalers and then distributed nationwide by internet and retail sales.
Stores named: Online Retailers
Questions about this recall
Is X-rock 3 Day Pill For Men, supplied in 1 and blister packs and 6, 12 recalled?
Yes. Coral Rock Man recalled X-rock 3 Day Pill For Men, supplied in 1 and blister packs and 6, 12 on 16 Jul 2012. The recall is Class I and its status is Terminated. Recall number D-038-2013.
Why was it recalled?
Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.
Which lots are affected?
All Lots All codes.
Where was it sold?
Product was distributed to three distributors/wholesalers and then distributed nationwide by internet and retail sales.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Coral Rock Man
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Z-rock All Natural Male Supplement recalled by Coral Rock Man | Coral Rock Man | Hidden Drug Ingredients | Nationwide |