# FDA recall D-1595-2020

> **The Protein Shoppe** · Class I · drug recall initiated 2020-09-01.

## Product

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

## Reason for recall

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.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1595-2020
- **Recalling firm:** The Protein Shoppe
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-09-01
- **Report date:** 2020-09-30
- **Termination date:** 2022-02-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pharr, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1595-2020

## Citation

> AI Analytics. FDA recall D-1595-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1595-2020. Source: US FDA. Licensed CC0.

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