CLASS I Food recall · Reported 22 Jan 2014 · FDA Enforcement Report

OxyELITE Pro Super Thermo Dietary Supplement recalled by USPlabs

USPlabs is recalling USPlabs OxyELITE Pro Super Thermo Dietary Supplement, distributed nationwide in the US. The recall was initiated on 9 Nov 2013 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codes2 count capsules, UPC # 094922417275; 10 count capsules, UPC # 094922417251; 10 count capsules, UPC # 094922417268; 21 count capsules, UPC # 094922426604; 90 count capsules, UPC # 094922395573; 90 count capsules "Pink Label", UPC # 094922447906; 180 count capsules, UPC # 094922447852
Quantity recalled2,166,328 units

Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.

Recall details

Recall number
F-1370-2014
FDA event ID
66813
Recalling firm
USPlabs, Dallas, TX
Classification
Class I
Status
Terminated
Recall initiated
9 Nov 2013
FDA classified
15 Jan 2014
Reported
22 Jan 2014
Type
Voluntary: Firm initiated
Customers notified by
Press Release
Reason category
Other Reasons
Product category
Dietary Supplements

Timeline

9 Nov 2013Recall initiated by company
15 Jan 2014Classified by FDA+67 days
22 Jan 2014Published in enforcement report+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure.

Product as listed by the FDA

USPlabs OxyELITE Pro Super Thermo DIETARY SUPPLEMENT Manufactured for USPlabs, LLC (Dallas, TX 75220), distributed in the following sizes: 2 count capsules; 10 count capsules; 21 count capsules; 90 count capsules; and 180 count capsules.

Where it was distributed

Worldwide distribution including the following Worldwide distribution including the following international countries: Ecuador, Russia, UAE, South America, Dominican Republic, Kuwait, Philippines, Indonesia, Egypt, Panama, China, and Argentina.

Nationwide

Questions about this recall

Is OxyELITE Pro Super Thermo Dietary Supplement recalled?

Yes. USPlabs recalled OxyELITE Pro Super Thermo Dietary Supplement on 9 Nov 2013. The recall is Class I and its status is Terminated. Recall number F-1370-2014.

Why was it recalled?

USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure.

Which lots are affected?

2 count capsules, UPC # 094922417275; 10 count capsules, UPC # 094922417251; 10 count capsules, UPC # 094922417268; 21 count capsules, UPC # 094922426604; 90 count capsules, UPC # 094922395573; 90 count capsules "Pink Label", UPC # 094922447906; 180 count capsules, UPC # 094922447852

Where was it sold?

Worldwide distribution including the following Worldwide distribution including the following international countries: Ecuador, Russia, UAE, South America, Dominican Republic, Kuwait, Philippines, Indonesia, Egypt, Panama, China, and Argentina.

What should I do if I have it?

Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.

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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