FDA Drug recall D-0105-2018
FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, distributed by Express Pac Trading, UPC 4026666146056
- FDA Drug
- Class I
- terminated
- Published 2017-12-13
On 2017-12-13 the FDA classified a Class I recall of FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, distributed by Express Pac Trading, UPC 4026666146056 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-0105-2018 |
| 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
FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, distributed by Express Pac Trading, UPC 4026666146056
Reason
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Identifiers
| upc | 4026666146056 |
|---|---|
| code_info | All Lots |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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FDA Drug · Class I · 2017-12-13 · Gadget Island
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0105-2018%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.