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

Lot, batch or date codesAll lots

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 2013Recall initiated by company
20 Mar 2014Classified by FDA+266 days
26 Mar 2014Published 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

Nationwide

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.

More recalls from Fabscout Entertainment

All 5