PapaZen 3300 capsule — Class I drug recall D-0104-2018
Terminated recall by Gadget Island, Inc, reported 2017-12-13, distributed nationwide. Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carb
| Recall number | D-0104-2018 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gadget Island, Inc, Newark, CA, United States |
| Recall initiated | 2017-09-15 |
| Classified | 2017-12-04 |
| Reported by FDA | 2017-12-13 |
| Terminated | 2018-12-04 |
| Distributed | Nationwide (US) |
| Reason classes | undeclared allergen, unapproved product |
| UPC / GTIN / UDI-DI | 00718122032587 |
| Lot numbers | NSS050888 |
| Expiration dates | 2018-05 |
Product
PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distributed by FX Power San Diego, CA 92108, UPC 718122032587
Reason for recall
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
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-0104-2018. 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.