Red-E Tablet — Class I drug recall D-1595-2020
Terminated recall by The Protein Shoppe, reported 2020-09-30, distributed nationwide. Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approved drug for t
| Recall number | D-1595-2020 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Protein Shoppe, Pharr, TX, United States |
| Recall initiated | 2020-09-01 |
| Classified | 2020-09-24 |
| Reported by FDA | 2020-09-30 |
| Terminated | 2022-02-08 |
| Distributed | Nationwide (US) |
| Quantity | 21,511 tablets |
| Reason classes | unapproved product |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1595-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.