FDA Drug recall D-0104-2018
PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distributed by FX Power San Diego, CA 92108, UPC 718122032587
- FDA Drug
- Class I
- terminated
- Published 2017-12-13
On 2017-12-13 the FDA classified a Class I recall of PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distributed by FX Power San Diego, CA 92108, UPC 718122032587 by Gadget Island, citing marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0104-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-09-15 |
| Published | 2017-12-13 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Gadget Island |
| Distribution | US |
Product
PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distributed by FX Power San Diego, CA 92108, UPC 718122032587
Reason
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Identifiers
| upc | 718122032587 |
|---|---|
| code_info | Lot# NSS050888, EXP 05-2018 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0104-2018%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.