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.
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.
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.
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.
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.
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.
Identify the product by checking the ASIN B08JCWG84D and barcode X002NI8PE1 on the carton.
The product contains undeclared tadalafil, an ingredient approved for male sexual enhancement, making it an unapproved drug.
The recall record does not specify a remedy, so check the product details and contact the manufacturer for guidance.
No, the product is not FDA-approved and contains an unapproved drug ingredient, which could pose health risks.
We’ve drafted a message you can send Positive Health to request your refund or repair — edit it as you like.
Subject: Recall D-0645-2022 — Positive Health Positive Health Hello, I own a Positive Health that is covered by recall D-0645-2022 from Positive Health. 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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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.
