Rock-It Man Capsules (Consumer Concepts) – Unapproved Ingredients (2013)
Class I: 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
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Consumer Concepts, Inc.
Lot Codes / Batch Numbers
All product sold between 01/01/13 through 03/27/13.
Products Sold
All product sold between 01/01/13 through 03/27/13.
Consumer Concepts, Inc. is recalling ROCK-IT MAN capsules, male sexual stimulant, packaged in 1-count (UPC 8 53447 02003 8) and 2-count ( due to Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain hydroxythiohomosildenafil, an analogue of sildenafil which is an ingr. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026