FDA Drug recall D-037-2013
X-ROCK For Men, Dietary Supplement, Manufactured by CRM Laboratories, Distributed by XRock Industries, PO Box 120863, Ft. Lauderdale, FL 33…
- FDA Drug
- Class I
- terminated
- Published 2012-11-07
On 2012-11-07 the FDA classified a Class I recall of X-ROCK For Men, Dietary Supplement, Manufactured by CRM Laboratories, Distributed by XRock Industries, PO Box 120863, Ft. Lauderdale, FL 33… by Xrock Industries, citing marketed Without an Approved NDA/ANDA: product tested positive for PDE-5 Sildenafil and PDE-5 Hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analog of sildenafil, an F….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-037-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-04-21 |
| Published | 2012-11-07 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Xrock Industries |
| Distribution | US |
Product
X-ROCK For Men, Dietary Supplement, Manufactured by CRM Laboratories, Distributed by XRock Industries, PO Box 120863, Ft. Lauderdale, FL 33312, 0 00309 50792 7. UPC on labeling is: 0 00309 50792 7. UPC in Press Release is: 0030950792.
Reason
Marketed Without an Approved NDA/ANDA: product tested positive for PDE-5 Sildenafil and PDE-5 Hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analog of sildenafil, an FDA approved prescription drug for Erectile Dysfunction (ED).
Identifiers
| upc | 000309507927 |
|---|---|
| code_info | UPC 0 00309 50792 7 All Lots |
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-037-2013%22
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