FDA Drug recall D-1595-2020
Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag stapled with cardboard labeling
- FDA Drug
- Class I
- terminated
- Published 2020-09-30
On 2020-09-30 the FDA classified a Class I recall of Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag stapled with cardboard labeling by The Protein Shoppe, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1595-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-09-01 |
| Published | 2020-09-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | The Protein Shoppe |
| Distribution | US |
Product
Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag stapled with cardboard labeling.
Reason
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.
Identifiers
| code_info | All lots. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1595-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.