FDA Drug recall D-325-2013
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, Dis…
- FDA Drug
- Class I
- terminated
- Published 2013-05-22
On 2013-05-22 the FDA classified a Class I recall of 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, Dis… by Consumer Concepts, citing marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain hydroxythiohomosildenafil, an analogue of sildenafil which is an ingredient in an FDA-approved dru….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-325-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-04-01 |
| Published | 2013-05-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Consumer Concepts |
| Distribution | US |
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.
Reason
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain hydroxythiohomosildenafil, an analogue of sildenafil which is an ingredient in an FDA-approved drug for the treatment of male erectile dysfunction, making this an unapproved new drug.
Identifiers
| upc | 853447020038 |
|---|---|
| upc | 853447002041 |
| code_info | All product sold between 01/01/13 through 03/27/13. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-325-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.