CLASS I Drug recall · Reported 18 Dec 2013 · FDA Enforcement Report
Volcano Male Enhancement Liquid, www.volcanoenhancement.com recalled
Myson is recalling Volcano Male Enhancement Liquid, www.volcanoenhancement.com, distributed nationwide in the US. The recall was initiated on 19 Jul 2013 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-344-2014
- FDA event ID
- 65762
- Recalling firm
- Myson, Long Beach, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 19 Jul 2013
- FDA classified
- 12 Dec 2013
- Reported
- 18 Dec 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
Timeline
| 19 Jul 2013 | Recall initiated by company | |
| 12 Dec 2013 | Classified by FDA | +146 days |
| 18 Dec 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
All lots including 0312-K2, Exp 11/14
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 65762This product is part of a recall event; the main page for the event is Volcano Male Enhancement 1500mg capsule recalled by Myson Corporation.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Volcano Male Enhancement 1500mg capsule recalled by Myson Corporation | Myson | Labeling Errors | Nationwide |
More recalls from Myson
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Volcano Male Enhancement 1500mg capsule recalled by Myson Corporation | Myson | Labeling Errors | Nationwide |