Recall events
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Event 78151
Event summary
Timeline bucket September 15, 2017
Product types Drug
Classifications Class I
Statuses Terminated
Recalling firm wording Gadget Island, Inc
Dossier provenance
Source snapshots represented here
openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Device root-cause evidence is not applicable to this event.
No grouped product has the official product type device; this is not an unavailable-enrichment finding.
Complete imported group
Every recalled product in this event
4 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
drug · product 1 of 4
RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packets, distributed by Fifty Shades Bayside, NY 11361, UPC 617135861224
D-0103-2018
Recall number D-0103-2018
Initiated September 15, 2017
Classification Class I
Status Terminated
Quantity 925 1-capsule packets
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[9404]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 4
PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distributed by FX Power San Diego, CA 92108, UPC 718122032587
D-0104-2018
Recall number D-0104-2018
Initiated September 15, 2017
Classification Class I
Status Terminated
Quantity 89 1-capsule packets
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Code information Lot# NSS050888, EXP 05-2018
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[9425]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 4
FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, distributed by Express Pac Trading, UPC 4026666146056
D-0105-2018
Recall number D-0105-2018
Initiated September 15, 2017
Classification Class I
Status Terminated
Quantity 273 1-capsule packets
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[9711]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 4
grande X 5800 capsule, (Maca Root 120 mg, Horny Goat Weed 120 mg, Guarana Seed 80 mg, Ginko Leaf 60 mg, Saw Palmetto 100 mg, Damiana Leaf 100 mg, Ginseng Root 80 mg, Tribulus Terrestris 90 mg, Tongkat Alo 100 mg, Rhodiola Rosea 60 mg, L-Arginine 90 mg), 1-capsule packets, distributed by Grande X Ontario, CA 91745, UPC 640793555440
D-0106-2018
Recall number D-0106-2018
Initiated September 15, 2017
Classification Class I
Status Terminated
Quantity 198 1-capsule packets
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[9423]
FDA event record
· Exact recall-number query on openFDA
