Food recall: Oxyphen XR, 12 HR / CLINICAL STRENGTH FAT BURNER, 45 FAST ACTING EXTENDED RELEASE CAPSULES, Distributed by Beta Labs…
Class I FDA enforcement event 65585. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The products contain DMAA, also known as 1,3-dimethylamylamine, methylhexamine or geranium extract, which is not permitted in dietary supplements.
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
Beta Labs started this food recall on 20 Jun 2013. The firm address in the FDA record is in Memphis, TN. FDA put the recall in Class I. FDA event 65585 has 4 product records. The first FDA enforcement report date is 3 Sep 2014. The record gives the status Terminated, with the termination date 3 Dec 2014.
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.
nationwide and UK
Recalling firm
Beta Labs, Memphis, TN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
4 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| F-2398-2014 | Oxyphen XR, 12 HR / CLINICAL STRENGTH FAT BURNER, 45 FAST ACTING EXTENDED RELEASE CAPSULES, Distributed by Beta Labs, LTD, Newark, DE 19711, UPC 670541599747 | 5951 units | Class II | Terminated | 3 Sep 2014 |
| F-2399-2014 | PHENTALENE (TM), PHARMACEUTICAL GRADE, With 50 mg of Ephedra Extract, 90 CAPSULES, Distributed by Beta Labs, LTD, Newark, DE 19711, UPC 670541599822 | 2154 units | Class I | Terminated | 3 Sep 2014 |
| F-2400-2014 | PHEnFX (TM), PHENO 550 mg, PHARMACEUTICAL GRADE, 90 CAPSULES, Manufactured for: Beta Labs, LTD, Newark, DE 19711, UPC 029882559802 | 743 units | Class II | Terminated | 3 Sep 2014 |
| F-2401-2014 | RED VIPERS, ADVANCED FOCUS AND CONCENTRATION, HEIGHTENED ENERGY LEVELS, 75mg EPHEDRA, Manufactured for: Beta Labs, LTD, Newark, DE 19711, UPC 029882559819 | 743 units | Class II | Terminated | 3 Sep 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
- Food events that started in 2013
- 546
- Share of these events in Class I
- 37%
- Product records in this event
- 4
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report F-2398-2014The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA: report a problemThe FDA page that shows where a report about a product goes.
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Cite this page
Recall Register. FDA enforcement event 65585. https://recallregister.com/fda/i/65585/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA food 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:
nationwide and UK
- What quantity of product is in FDA event 65585?
- The event has 4 product records. The first record gives this quantity:
5951 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many food recalls of 2013 have the same class?
- 37% of the 546 food events that started in 2013 are in Class I.