The Protein Shoppe recalls Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag stapled with cardboard labeling.

Recall date

September 1, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1595-2020

FDA classification

Class I

Brand / firm

The Protein Shoppe

Sold / distributed

Nationwide in the USA

Why it was recalled

Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug fro which the safety and efficacy have not been established and therefore subject to recall.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag stapled with cardboard labeling.