Vitility MAN OF STEEL Capsules: Unapproved Sildenafil Risk
FDA recalls Vitility's MAN OF STEEL capsules (3000mgs/grain) due to undeclared sildenafil, an unapproved drug with unknown safety.
Recall notice
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
Contact the company & request your remedy
What happened, in plain English
Vitility is recalling MAN OF STEEL capsules because they contain undeclared sildenafil, an FDA-approved drug for erectile dysfunction that was not approved for this product. This makes the capsules unapproved and potentially unsafe. Read more at govinfonow.com/recall/41542-vitility-man-of-steel-capsules-unapproved-sildenafil-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41542-vitility-man-of-steel-capsules-unapproved-sildenafil-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0032-2018
Cite this page
“Vitility MAN OF STEEL Capsules: Unapproved Sildenafil Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41542-vitility-man-of-steel-capsules-unapproved-sildenafil-risk. Based on FDA recall #D-0032-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0032-2018%22&limit=1).
Why it’s dangerous
The capsules contain undeclared sildenafil, an FDA-approved drug for erectile dysfunction. Since this product was marketed without an approved NDA/ANDA, its safety and effectiveness have not been established by the FDA.
Who’s affected
People who purchased Vitility's MAN OF STEEL capsules (3000mgs/grain, 1-count packets) from the listed seller. Those using the product for medical purposes without FDA approval are at higher risk.
How to tell if you have this one
Look for MAN OF STEEL capsules labeled 3000mgs/grain, 1-count packets. They were packaged for One Drop Solutions, LLC in Sacramento, California, with no lot number and an expiration date of 10-17-2018.
- Brand
Vitility- Category
Drug
What to do — step by step
Check Product Details
Verify if your capsules are labeled 3000mgs/grain, 1-count packets with no lot number and expiration date 10-17-2018.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Contact Vitility
We’ve drafted a message you can send Vitility to request your refund or repair — edit it as you like.
Subject: Recall D-0032-2018 — Vitility MAN OF STEEL Capsules: Unapproved Sildenafil Risk Hello, I own a Vitility MAN OF STEEL Capsules: Unapproved Sildenafil Risk that is covered by recall D-0032-2018 from Vitility. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0032-2018 (June 22, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0032-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.