Recall events
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Event 87711
Event summary
Timeline bucket April 06, 2021
Product types Drug
Classifications Class II
Statuses Ongoing
Recalling firm wording Hyobin LLC
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
3 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 3
PremierZen Extreme 3000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
D-0381-2021
Recall number D-0381-2021
Initiated April 06, 2021
Classification Class II
Status Ongoing
Quantity 500 cards
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Distribution pattern USA Nationwide
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[12340]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 3
PremierZen Black 5000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
D-0382-2021
Recall number D-0382-2021
Initiated April 06, 2021
Classification Class II
Status Ongoing
Quantity 500 cards
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Distribution pattern USA Nationwide
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[12920]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 3
Triple SupremeZen Plus 3500, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
D-0383-2021
Recall number D-0383-2021
Initiated April 06, 2021
Classification Class II
Status Ongoing
Quantity 300 cards
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Distribution pattern USA Nationwide
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[12223]
FDA event record
· Exact recall-number query on openFDA
