US Drug Recall Register
Class I · High risk Terminated Initiated Sep 1, 2020 (6 years ago)

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

Class I — High risk. Reasonable probability of serious harm or death.

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.

What was recalled

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

Recalling firm
The Protein Shoppe
Origin
TX, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1595-2020

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.