THE RED PILL EXTRA STRENGTH Capsules Recalled for Undeclared Tadalafil
THE RED PILL EXTRA STRENGTH 800 mg capsules are being recalled because they contain undeclared tadalafil, an active ingredient in FDA-approved sexual-enhancement medications. The product was marketed and distributed as an unapproved drug nationwide via Amazon.
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 has classified this recall as Class I, the most serious classification. The source text indicates the product was marketed without an approved NDA/ANDA and contains an undeclared active pharmaceutical ingredient, meeting the threshold for Class I recall severity.
Plain-English summary
Your Favorite Shop is recalling THE RED PILL, EXTRA STRENGTH capsules, 800 mg (Lot # 26436989, expiration date 10/30/2023), packaged in 10-count blisters within cartons, ASIN B0847BSQQ5, Barcode X002G5GMJ1. Approximately 12,500 cartons were distributed nationwide in the USA through Amazon Marketplace.
The product was found to contain undeclared tadalafil, an ingredient used in FDA-approved medications for male sexual enhancement. Because this ingredient was not declared and the product lacks an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), it is an unapproved drug.
Consumers who have purchased this product should not use it and may contact their healthcare provider with questions about potential exposure to undeclared tadalafil.
The recalled product
- Product
- THE RED PILL, EXTRA STRENGTH capsules, 800 mg, packaged in 10-count blisters packaged in a carton, ASIN B0847BSQQ5, Barcode X002G5GMJ1.
- Manufacturer
- Your Favorite Shop
- Hazard
- undeclared-tadalafil
- unapproved-drug
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 # 26436989
- Exp. date 10/30/2023
Distribution
Distributed nationwide across the United States.
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