The Recall Desk
CriticalFDA (Drugs)·D-1595-2020·Announced 2020-09-30

Protein Shoppe Recalls Red-E Tablets Tainted With Sildenafil

The Protein Shoppe is recalling Red-E Tablets found to contain sildenafil, an unapproved drug for erectile dysfunction. The product was marketed without FDA approval.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

The Protein Shoppe is recalling Red-E Tablets, a proprietary blend packaged in 1-count plastic bags with cardboard labeling. The recall involves 21,511 tablets distributed nationwide in the USA. All lots are affected.

The FDA identified that the product was tainted with sildenafil, a drug approved for the treatment of male erectile dysfunction. Because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), it is considered an unapproved drug for which safety and efficacy have not been established.

Consumers who have purchased these products should stop using them and contact The Protein Shoppe for further instructions or a refund.

The recalled product

Product
Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag stapled with cardboard labeling.
Manufacturer
The Protein Shoppe
Category
Drug — Unapproved Dietary Supplement
Hazard
Affected units
21,511

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 (1)

  • All lots.

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · unapproved drug

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