7K capsules packaged in single packs sold in 24-count boxes — Class I drug recall D-0880-2018
Terminated recall by Shoreside Enterprises Inc., reported 2018-06-06, distributed nationwide. Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadala
| Recall number | D-0880-2018 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shoreside Enterprises Inc., Tampa, FL, United States |
| Recall initiated | 2018-05-17 |
| Classified | 2018-06-18 |
| Reported by FDA | 2018-06-06 |
| Terminated | 2020-06-10 |
| Distributed | Nationwide (US) |
| Reason classes | undeclared allergen, unapproved product |
| UPC / GTIN / UDI-DI | 00601577513148 |
| Expiration dates | 2021-12-31 |
Product
7K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co. San Diego, CA 92108, UPC 601577513148
Reason for recall
Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which 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-0880-2018. 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.