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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- 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
See all →- CriticalBuy-Herbal Recalls Kian Pee Wan Capsules for Undeclared Drug Ingredients
FDA (Drugs) · 2026-08-19
- SevereMR. 7 Super capsules recalled as Class I over undeclared sildenafil
FDA (Drugs) · 2026-03-11
- SevereMojo Max Fusion capsules recalled as Class I over undeclared drug ingredients
FDA (Drugs) · 2026-03-11
- SevereSilintan herbal pills recalled as Class I for undeclared meloxicam
FDA (Drugs) · 2026-03-11
- SevereAgebox iKids-Growth Day Formula Capsules Recalled Over Undeclared Drug Ingredient
FDA (Drugs) · 2026-03-04
Similar recalls
- CriticalAPEXXX tablets recalled for containing unapproved sildenafil
FDA (Drugs) · 2016-02-24
- CriticalRed Zone Xtreme 3000 Capsules Recalled for Undeclared Tadalafil
FDA (Drugs) · 2018-04-04
- SevereTHE RED PILL EXTRA STRENGTH Capsules Recalled for Undeclared Tadalafil
FDA (Drugs) · 2022-02-23
- SevereRISE UP RED EDITION Capsules recalled for undeclared tadalafil
FDA (Drugs) · 2022-03-02
- SevereSuper Power capsules recalled for containing unapproved sildenafil
FDA (Drugs) · 2013-05-22
- SevereFDA Recalls Unapproved Power V8 Viagra Tablets Containing Sildenafil
FDA (Drugs) · 2018-02-07