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.
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 2
Volcano Male Enhancement Liquid, 2 FL OZ (60 ml) bottle, www.volcanoenhancement.com, DISTRIBUTED BY VOLCANO Long Beach, CA 90813, UPC 6 09613 85996 0.
Marketed Without An Approved NDA/ANDA: All lots of Volcano Liquid and Volcano Capsules, marketed as dietary supplements, are being recalled because they were found to contain undeclared active pharmaceutical ingredients, making them unapproved new drugs.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Marketed Without An Approved NDA/ANDA: All lots of Volcano Liquid and Volcano Capsules, marketed as dietary supplements, are being recalled because they were found to contain undeclared active pharmaceutical ingredients, making them unapproved new drugs.
Code information
All lots including 0312-K2, Exp 11/14
Distribution pattern
Nationwide
drug · product 2 of 2
Volcano Male Enhancement 1500mg, 1-count capsule packaged in a black round plastic pop top container, (Proprietary Formula, Pueraria lobata, Cinnamon Bark, Cuscuta, Gui, Licorice, Altractylodes, Dang Condonopsis, Dismutase, Cornus, Rubus, Deng Sen Extract, Panax Ginseng, Cordyceps Sinensis, Go Ji Extract, Superoxide Dismutase).
Marketed Without An Approved NDA/ANDA: All lots of Volcano Liquid and Volcano Capsules, marketed as dietary supplements, are being recalled because they were found to contain undeclared active pharmaceutical ingredients, making them unapproved new drugs.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Marketed Without An Approved NDA/ANDA: All lots of Volcano Liquid and Volcano Capsules, marketed as dietary supplements, are being recalled because they were found to contain undeclared active pharmaceutical ingredients, making them unapproved new drugs.
