FDA Drug recall D-0880-2018
7K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co. San Diego, CA 92108, UPC 601577513148
- FDA Drug
- Class I
- terminated
- Published 2018-06-06
On 2018-06-06 the FDA classified a Class I recall of 7K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co. San Diego, CA 92108, UPC 601577513148 by Shoreside Enterprises, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0880-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2018-05-17 |
| Published | 2018-06-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Shoreside Enterprises |
| Distribution | US |
Product
7K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co. San Diego, CA 92108, UPC 601577513148
Reason
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.
Identifiers
| upc | 601577513148 |
|---|---|
| code_info | Lot #: RO, Exp. 12/31/2021 |
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-0880-2018%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.