Positive Health RISE UP RED EDITION Capsules: Unapproved Drug Risk
Positive Health recalls RISE UP RED EDITION Capsules (650mg, 10-count) due to containing undeclared tadalafil, an unapproved drug ingredient. This product is not FDA-approved and poses health risks.
Recall notice
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
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What happened, in plain English
Positive Health is recalling RISE UP RED EDITION Capsules (650mg, 10-count) because they contain undeclared tadalafil, an ingredient approved for male sexual enhancement. This makes the product an unapproved drug that could pose health risks. Read more at govinfonow.com/recall/35226-positive-health-rise-up-red-edition-capsules-unapproved-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/35226-positive-health-rise-up-red-edition-capsules-unapproved-drug-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0645-2022
Cite this page
“Positive Health RISE UP RED EDITION Capsules: Unapproved Drug Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35226-positive-health-rise-up-red-edition-capsules-unapproved-drug-risk. Based on FDA recall #D-0645-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0645-2022%22&limit=1).
Why it’s dangerous
The capsules contain undeclared tadalafil, an ingredient approved for male sexual enhancement. This makes the product an unapproved drug that could cause health issues if used without proper medical supervision.
Who’s affected
Anyone who owns or uses these capsules is affected. People most at risk are those who have taken the capsules without knowing they contain an unapproved drug ingredient.
How to tell if you have this one
Check for the RISE UP RED EDITION Capsules, 650 mg, 10-count blisters in a carton with ASIN B08JCWG84D and barcode X002NI8PE1. The product was sold with lot # 48658908 and expired on 09/09/2023.
- Brand
Positive Health- Category
Drug
What to do — step by step
Check Product Details
Identify the product by checking the ASIN B08JCWG84D and barcode X002NI8PE1 on the carton.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Product was distributed nationwide via the internet through Amazon Marketplace.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 4 months after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class I
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0645-2022 (February 10, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0645-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.