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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

The Protein Shoppe: Red-E Tablets Recalled for Undeclared Sildenafil Contamination

Agency Publication Date: September 24, 2020
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Summary

The Protein Shoppe is recalling approximately 21,511 Red-E Tablets, a proprietary dietary supplement blend (3000 mg), because they were found to contain sildenafil. Sildenafil is a prescription drug used for the treatment of erectile dysfunction that was not declared on the product label. Consumers who have purchased these products, which were sold in 1-count plastic bags stapled with cardboard labeling across all lots, should immediately stop using them. Because the safety and efficacy of this unapproved drug have not been established, consumers should contact their healthcare provider for guidance regarding any health concerns.

Risk

The product is contaminated with sildenafil, which can interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and are at significant risk of life-threatening health consequences from this interaction.

What You Should Do

  1. Identify the affected product by checking for 'Red-E Tablet, Proprietary Blend 3000 mg' packaged in a single-count plastic bag stapled to a cardboard label.
  2. Check the product packaging for Recall Number D-1595-2020; note that all lot numbers of this product are affected by this recall.
  3. Stop using the tablets immediately and do not consume any remaining product.
  4. Contact your healthcare provider or pharmacist for guidance if you have consumed this product, especially if you take prescription medications containing nitrates.
  5. Return any unused product to the place of purchase for a full refund and contact The Protein Shoppe at 101 E Interstate 2, Pharr, Texas, for further instructions.
  6. For additional questions or to report a related health issue, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Drug recall baseline remedy

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Red-E Tablet, Proprietary Blend 3000 mg
Model:
Recall #: D-1595-2020
Lot Numbers:
All lots

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86377
Status: Resolved
Manufacturer: The Protein Shoppe
Manufactured In: United States
Units Affected: 21,511 tablets
Distributed To: Nationwide

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 · 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.