RISE UP RED EDITION Capsules recalled for undeclared tadalafil
RISE UP RED EDITION Capsules, 650 mg, have been recalled because they contain undeclared tadalafil, an ingredient found in FDA-approved male sexual enhancement products. The product is an unapproved drug and was distributed nationwide via Amazon Marketplace.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I, which per the rubric mandates a minimum score of 4. An unapproved drug containing an undeclared prescription ingredient poses serious health risks through unexpected pharmacological effects and potential drug interactions.
Plain-English summary
RISE UP RED EDITION Capsules, 650 mg, packaged in 10-count blisters in cartons (ASIN B08JCWG84D, barcode X002NI8PE1) have been recalled. The product was manufactured by Positive Health.
The recall was issued because the product contains undeclared tadalafil, an ingredient found in FDA-approved products for male sexual enhancement. Because the product contains this ingredient but lacks an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), it is classified as an unapproved drug.
Approximately 5,500 cartons of the product were distributed nationwide via the internet through Amazon Marketplace. The affected lot is #48658908 with an expiration date of 09/09/2023.
Consumers who have purchased this product should stop use and consult a healthcare provider if they have any health concerns.
The recalled product
- Product
- RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.
- Manufacturer
- Positive Health
- Category
- Drug — Unapproved Drug
- Hazard
- unapproved-drug
- undeclared-ingredient
- tadalafil
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 48658908
- Exp. date 09/09/2023
Distribution
Distributed nationwide across the United States.
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