Organic Herbal Supply recalls XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 500 mg capsules, 2, 4 and 10 count boxes, Made in
Organic Herbal Supply recalls XtraHRD Natural Male Enhancement Capsules due to containing unapproved tadalafil analogues. This herbal supplement may pose risks for users seeking erectile dysfunction treatment.
Recall notice
Marketed without an Approved NDA/ANDA: Product contains N-desmethyl tadalafil an analogue to tadalafil which is an active pharmaceutical ingredient in a FDA approved drug used to treat erectile dysfunction (ED).
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What happened, in plain English
Organic Herbal Supply is recalling XtraHRD Natural Male Enhancement Capsules because they contain N-desmethyl tadalafil, an unapproved drug analogue of tadalafil used for erectile dysfunction. This product was marketed without FDA approval and could pose health risks to users. Read more at govinfonow.com/recall/41942-xtrahrd-natural-male-enhancement-capsules-unapproved-tadalafil-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41942-xtrahrd-natural-male-enhancement-capsules-unapproved-tadalafil-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0646-2017
Cite this page
“XtraHRD Natural Male Enhancement Capsules: Unapproved Tadalafil Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41942-xtrahrd-natural-male-enhancement-capsules-unapproved-tadalafil-risk. Based on FDA recall #D-0646-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0646-2017%22&limit=1).
Why it’s dangerous
The product contains N-desmethyl tadalafil, a chemical similar to tadalafil (an FDA-approved drug for erectile dysfunction). Because this product was marketed without FDA approval, it may cause health risks such as unintended drug interactions or side effects.
Who’s affected
Anyone who purchased XtraHRD Natural Male Enhancement Capsules from Organic Herbal Supply. Men using these capsules for erectile dysfunction treatment are at higher risk due to the unapproved active ingredient.
How to tell if you have this one
Check for XtraHRD Natural Male Enhancement Capsules with 500 mg capsules in 2, 4, or 10 count boxes. The product was made in Malaysia and distributed by Naturally Hard Supplements in Reno, NV.
- Brand
Organic Herbal Supply- Product
XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 500 mg capsules, 2, 4 and 10 count boxes, Made in- Category
Drug
What to do — step by step
Check Product Details
Look for the product name, count, and box type to confirm if it matches the recalled items.
Questions people ask
Is this product safe to use?
The product was marketed without FDA approval and contains an unapproved drug analogue, so it may pose health risks. The official recall does not specify if it's safe to use.
What should I do if I have this product?
The recall record does not specify a remedy, so no action is required beyond checking if you have the product.
How can I tell if I have the recalled product?
Check for XtraHRD Natural Male Enhancement Capsules with 500 mg capsules in 2, 4, or 10 count boxes, made in Malaysia, distributed by Naturally Hard Supplements in Reno, NV.
Contact Organic Herbal Supply
We’ve drafted a message you can send Organic Herbal Supply to request your refund or repair — edit it as you like.
Subject: Recall D-0646-2017 — Organic Herbal Supply XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 500 mg Hello, I own a XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 500 mg capsules, 2, 4 and 10 count boxes, Made in that is covered by recall D-0646-2017 from Organic Herbal Supply. 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-0646-2017 (February 16, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0646-2017 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.