CLASS I Drug recall · Reported 28 May 2014 · FDA Enforcement Report
Xzone Gold blister 750 mg recalled by Schindele Enterprises
Schindele Enterprises is recalling Xzone Gold blister 750 mg, distributed in 13 states. The recall was initiated on 9 Jan 2014 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-1334-2014
- FDA event ID
- 67228
- Recalling firm
- Schindele Enterprises, Nixa, MO
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 9 Jan 2014
- FDA classified
- 20 May 2014
- Reported
- 28 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
Timeline
| 9 Jan 2014 | Recall initiated by company | |
| 20 May 2014 | Classified by FDA | +131 days |
| 28 May 2014 | Published in enforcement report | +8 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: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Product as listed by the FDA
XZONE GOLD, 1 capsule blister 750 mg, Distributed by: XZONE, Orlando, FL.
Where it was distributed
Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI
CaliforniaConnecticutFloridaGeorgiaIowaIllinoisLouisianaMarylandNevadaNew YorkPennsylvaniaTexasWisconsin
Questions about this recall
Is Xzone Gold blister 750 mg recalled?
Yes. Schindele Enterprises recalled Xzone Gold blister 750 mg on 9 Jan 2014. The recall is Class I and its status is Terminated. Recall number D-1334-2014.
Why was it recalled?
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Which lots are affected?
Lot # 130710GL, Exp. 07/31/2018
Where was it sold?
Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI
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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