CLASS I Drug recall · Reported 26 Mar 2014 · FDA Enforcement Report
Silver Sword capsules, 180 mg clamshell tin recalled
Fabscout Entertainment is recalling Silver Sword capsules, 180 mg clamshell tin, distributed nationwide in the US. The recall was initiated on 27 Jun 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-1170-2014
- FDA event ID
- 65892
- Recalling firm
- Fabscout Entertainment, Ft Lauderdale, FL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 27 Jun 2013
- FDA classified
- 20 Mar 2014
- Reported
- 26 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
Timeline
| 27 Jun 2013 | Recall initiated by company | |
| 20 Mar 2014 | Classified by FDA | +266 days |
| 26 Mar 2014 | 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: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient.
Product as listed by the FDA
Silver Sword capsules, 180 mg, 16-count clamshell tin, UPC 1 234658 970128 12345 (labeling is in foreign language)
Where it was distributed
Nationwide and France
Questions about this recall
Is Silver Sword capsules, 180 mg clamshell tin recalled?
Yes. Fabscout Entertainment recalled Silver Sword capsules, 180 mg clamshell tin on 27 Jun 2013. The recall is Class I and its status is Terminated. Recall number D-1170-2014.
Why was it recalled?
Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient.
Which lots are affected?
All lots
Where was it sold?
Nationwide and France
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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