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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Dietary Supplements

Rise Up Red Edition Capsules Recalled for Undeclared Tadalafil

Agency Publication Date: February 24, 2022
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Summary

Positive Health is recalling approximately 5,500 cartons of RISE UP RED EDITION Capsules (650 mg), a product marketed for male sexual enhancement. The capsules were found to contain undeclared tadalafil, which is the active pharmaceutical ingredient in FDA-approved prescription drugs used to treat erectile dysfunction. No injuries or incidents have been reported in connection with this product to date.

Risk

The undeclared tadalafil in this product can interact with nitrates found in some prescription drugs, such as nitroglycerin, which may lower blood pressure to dangerous or life-threatening levels. This poses a significant health risk to consumers with diabetes, high blood pressure, high cholesterol, or heart disease who may be taking nitrates.

What You Should Do

  1. This recall affects RISE UP RED EDITION Capsules (650 mg) sold in 10-count blister packs packaged in a carton.
  2. Identify the affected product by looking for Lot # 48658908 with an expiration date of 09/09/2023, ASIN B08JCWG84D, and barcode X002NI8PE1.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: RISE UP RED EDITION Capsules (650 mg)
Variants: 650 mg, 10-count blister pack
Model:
ASIN B08JCWG84D
X002NI8PE1
Lot Numbers:
48658908 (Exp 09/09/2023)

Distributed nationwide via Amazon Marketplace.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89606
Status: Resolved
Manufacturer: Positive Health
Sold By: Amazon Marketplace
Manufactured In: United States
Units Affected: 5,500 cartons
Distributed To: Nationwide
Agency Last Updated: March 4, 2022

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.