Drug recall: XZONE GOLD, 1 capsule blister 750 mg, Distributed by: XZONE, Orlando, FL.
Class I FDA enforcement event 67228. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Schindele Enterprises dba Midwest Wholesale started this drug recall on 9 Jan 2014. The firm address in the FDA record is in Nixa, MO. FDA put the recall in Class I. FDA event 67228 has 7 product records. The first FDA enforcement report date is 28 May 2014. The record gives the status Terminated, with the termination date 3 Feb 2015.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI
Recalling firm
Schindele Enterprises dba Midwest Wholesale, Nixa, MO.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
7 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1334-2014 | XZONE GOLD, 1 capsule blister 750 mg, Distributed by: XZONE, Orlando, FL. | 175 blister packs | Class I | Terminated | 28 May 2014 |
| D-1335-2014 | BOOST ULTRA, sexual enhancement dietary supplement, 12-capsule/bottle. Also packaged in 3 pill bottles and 1 pill packs. BoostUtra.com, Springfield, MO. | 500 1-ct blisters; 30 3-ct bottles, 4 12-ct bottles | Class I | Terminated | 28 May 2014 |
| D-1336-2014 | SEXY MONKEY, 2000 mg, 1 count blister, Distributed by A Herbal Bio, Inc., Bayside, NY. | 2 blister packs | Class I | Terminated | 28 May 2014 |
| D-1337-2014 | MiracleZEN Platinum, 1 pill blister pack, 2000 mg capsule, Distributed by: Power Life Distributors, COK Inc., Los Angeles, CA. | 49 blister packs | Class I | Terminated | 28 May 2014 |
| D-1338-2014 | Magic For Men, packaged in 1ct blister pack and 12-pill/bottle, 390 mg Manufactured For: BTQ Ski, Inc., Chicago, IL 60638 | 59/1-ct blister pack, 97/12-ct bottles | Class I | Terminated | 28 May 2014 |
| D-1339-2014 | ExtenZe 600 mg, 30 tablet box, Manufactured for: Biotab Nutraceuticals, Inc., Pasadena, CA. | 57 boxes | Class I | Terminated | 28 May 2014 |
| D-1340-2014 | XZEN PLATINUM, 750 mg, Distributed by: XZEN, Los Angeles, CA. | 89 blister packs | Class I | Terminated | 28 May 2014 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Drug events that started in 2014
- 313
- Share of these events in Class I
- 15%
- Product records in this event
- 7
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report D-1334-2014The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 67228. https://recallregister.com/fda/i/67228/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI
- What quantity of product is in FDA event 67228?
- The event has 7 product records. The first record gives this quantity:
175 blister packs
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2014 have the same class?
- 15% of the 313 drug events that started in 2014 are in Class I.