X-ROCK For Men — Class I drug recall D-037-2013
Terminated recall by XRock Industries, LLC, reported 2012-11-07, distributed nationwide. Marketed Without an Approved NDA/ANDA: product tested positive for PDE-5 Sildenafil and PDE-5 Hydroxythiohomos
| Recall number | D-037-2013 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | XRock Industries, LLC, Pompano Beach, FL, United States |
| Recall initiated | 2012-04-21 |
| Classified | 2012-11-01 |
| Reported by FDA | 2012-11-07 |
| Terminated | 2015-11-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BM, BS, CA, CW, GB, HR, JM, NZ, TT |
| Quantity | 215,000 capsules |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 00000309507927 |
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 for recall
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-037-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.